Clinical Project Manager Jobs

Job Title: Associate Director/Sr. Clinical Project Manager:Global Studies, North NJ, $130k+ Company: Cornerstone Search Group, LLC Location: East Rutherford, NJ Description: Associate Director/Sr. Clinical Project Manager:Global Studies, North NJ, $130k+ Our client is looking for a seasoned Clinical Research professional to actively manage multiple global clinical study teams across therapeutic areas.  You will manage people on a project basis and not have to be weighed down with hiring/firing responsibilities.  Our client is an industry leading pharmaceutical company with an excellent reputation as an employer that takes care of their people and is rated year in and year out as a top employer to work for.  Compensation is competitive and benefits are very strong. Note: All inquiries and submissions are held in strict confidence (see our privacy policy below).   Position Title: Associate Director/Sr. Manager, Global Clinical Studies Company Description: Our client is an industry leading pharmaceutical company that has a stellar reputation.  Not only do they have numerous marketed products and pipelines in multiple therapeutic areas, but they are also rated as a top company to work for by numerous large publications.  Just this past year they were ranked as the Pharmaceutical Company of the Year.  Location: East Rutherford, New Jersey areaAttractive features about this position and company: International Trials:  Work across a number of therapeutic areas on a global level.This Company is continuing to grow an already robust Clinical Research and Development department with multiple leading products.Great location for those not only in NJ (North/East/West/Central), but also from NYC, Southern CT, or NY counties north of NYC.  Easily accessible from Route 80, 46, 287, and 3 as well as the NJ Turnpike and Garden State Parkway.Firm has a strong reputation for taking care of its people. Compensation/Benefits: Base compensation will be competitive and can range depending on your experience.  This will also include a double-digit bonus and top-tier benefits including: 100% tuition reimbursement, a generous 401(k) plan, and exceptional on-site facilities/perks including Child Care, Staff Training, Fitness Center, etc. Responsibilities, Challenges, Expectations and Deliverables for this position: In a nutshell, you will be responsible for leading multiple global study teams.  This is a strategy-based position where you oversee Clinical Research Managers who handle the day-to-day responsibilities.Proactively participate in leading teams as well as any process improvement plans.Manage the overall strategic goals/deliverables on a number of different studies/therapeutic areas.Involvement in ensuring that all resources and study related materials are available on all projects.Ensure that all site feedback and/or problems are handled in a timely and professional manner. Experiences, Skills, Accomplishments and Qualities Desired: BS/BA degree in a scientific or life sciences.  Advanced degree is preferred.7-10 years of clinical research experience.  They will consider someone with a few years of true study management responsibilities.Direct report/people management experience is not required.Multiple therapeutic areas acceptable. Must have exceptional leadership skills.Must be able to see the bigger picture (ie. strategic perspective, global orientation, collaborative thought process, etc.) Other OpportunitiesOur firm specializes in Pharmaceutical recruiting for firms located in NJ, NYC, and the surrounding areas. In addition to this opportunity, we are helping many of our other clients, located in Central NJ, Northern NJ, and NYC, on other CRA, SR. CRA and Clinical Project Management full time and consulting positions. For description of those opportunities, please visit our site www.cornerstonesg.com. Cornerstone’s Privacy PolicyCornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information.  This information will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact:Thomas FasciaManager, Specialized Pharmaceutical Practice Register to View  Cornerstone Search Group, LLC6 Campus DrParsippany, NJ 07054P Register to View x717F Register to View Web/URL: www.cornerstonesg.com  About Cornerstone Search Group, LLCCornerstone Search Group is a specialty pharmaceutical recruiting firm located in the heart of New Jersey's Pharmaceutical Corridor. We help our clients hire experienced pharmaceutical professionals from the Staff through Management (VP/Director) levels for Full-Time and Contract positions. We provide our professional recruiting services on a Contingency, Retingency, or Retained basis to best suit the hiring needs of our clients. RECRUITING FROM STAFF THROUGH MANAGEMENT LEVELS IN:Biostatistics and SAS ProgrammingClinical Operations (CRAs, Project Managers, Management)Clinical Research Data Management  / Clinical ProgrammingDrug InformationDrug SafetyHuman ResourcesInformation TechnologyMarketing / Market ResearchMedical DirectorsMedical Science LiaisonMedical WritingProduct ManagementQA/QCRegulatory Affairs Building better companies.  Building better careers.®

Job Title: Clinical Research Manager-Oncology (Phase II, III): Reputable NJ Pharma Company: Cornerstone Search Group, LLC Location: Morristown, NJ Description: Clinical Research Manager-Oncology (Phase II, III): Reputable NJ Pharma Join a leading Global Pharmaceutical Company and work within their renowned Oncology group. This is a challenging managerial opportunity within clinical research where you will be responsible for all aspects of one or more global clinical trials (Phase II through lifecycle management), while also working alongside some of the brightest minds in the Industry. Not only does this company have a top-notch drug development pipeline, they are consistently rated as one of the best pharmaceutical companies to work for. Please read on for further details… Location: Morristown, NJ areaPosition: Clinical Research Manager Compensation: Base compensation could range from $90-120k (plus an annual bonus and one of the most competitive benefits packages in the pharmaceutical industry). Attractive features about this position and company: A challenging opportunity where you will be able to put your clinical research experience to the test. A Pharmaceutical Industry Leader. Work for a Global Pharmaceutical Company that is well established, successful, and growing. Ideal Size: Be a part of a prestigious/medium-sized group of oncology professionals, while also having the tremendous financial stability of a prominent company. Growth & Advancement: we’ve seen promotional advancement based on merit/performance, as opposed to bureaucratic reasons. Nutshell Description: Responsible for all aspects of one or more clinical trial(s) (Phase II through lifecycle management) under the leadership of the therapeutic area group head. Responsible for program level activities as assigned: Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards. Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepare clinical outsourcing specifications. Responsible for the management of CROs and ensure adherence to scope of work within timelines and budget. Prepare training materials and presentations related to the planning and conduct of the trial. Actively involved in protocol development, CRF design and review, etc. Manage interactions with Global Clinical Development Operations and other relevant functions Support the development, management and tracking of trial budget working closely with the Therapeutic Area program operations group. Requirements: Bachelor degree in life science/healthcare required. Advanced degree preferred. 4+ years of experience in clinical research at a pharmaceutical company or CRO Oncology experience is a plus. Involvement in cross-functional, multicultural and international clinical trials. Cornerstone Search Group’s Privacy Policy: Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact: Brian C. Skurka Recruiter, Specialized Pharmaceutical Practice Cornerstone Search Group, LLC 6 Campus Dive Parsippany, NJ 07054 P Register to View Register to View Web/URL: www.cornerstonesg.com

Job Title: Clinical Research Manager Company: Location: Kannapolis, NC Description:             LOVELACE RESPIRATORY RESEARCH INSTITUTE ...        Giving the Gift of Breath     Clinical Research Manager  Job # NC17208   The Center for Pharmacoeconomic and Outcomes Research (CPOR) of the Lovelace Respiratory Research Institute (LRRI), is looking for a Clinical Research Manager who will provide management of the phase 1 clinical research program. Performs a variety of scientific and management duties including, but not limited to; protocol development, trials coordination, manuscript and report preparation, overseeing clinical trial site compliance with GCP and ICH, serving as the primary interface between the clinical research program and other related entities of LRRI including site management, pre-clinical drug development, and external partners. Requirements Educational requirement: Masters degree in pharmacology, epidemiology, experimental psychology or PharmD. Experience required: three (3) years of phase 1 protocol development experience for a medium/large pharmaceutical manufacturer and/or CRO. Must be proficient in computer software packages (Word, Excel, Access and PowerPoint), knowledge of GCP, ICH, and CFR as applied to drug development.  Must have experience planning/coordinating phase 1 clinical trials, maintaining/managing protocols, and interacting with scientific, medical, data management, monitoring, and site coordination functions.  Significant opportunity for growth available.   The position will be located at the North Carolina Research Campus in Kannapolis, NC.   We are looking for a highly motivated individual who has the ability to work independently in a multi-tasking environment.          Please send CV, referencing Job #NC17208 to: HR Office 2425 Ridgecrest Drive SE Albuquerque, NM 87108 Fax: Register to View E-mail: [Click Here to Email Your Resumé].   Visit: www.lrri.org.   EOE/MF

Job Title: CLA005 Clinical Project Manager Company: CR Bard Location: Tempe, AZ Description: Manages and leads the development and implementation process of project activities involving departmental, cross-functional and outsourced teams for new or existing projects. Plans and directs schedules and may monitor project budget/spending. Monitors the project from initiation through delivery. Organizes the internal and external project activities ensuring completion of the project on schedule and within budget constraints. Manages the execution of the day-to-day work results for projects. Ensures that projects are completed in accordance with project and regulatory requirements. Schedules, supervises and ensures the delivery of services provided by internal and external teams. - Evaluates project objectives and scope for feasibility. - Facilitates the identification and documentation of project requirements. - Develops and implements the project plan and resource requirements. - Coordinates the protocol/CRF development process. - Coordinates the development and submission of clinical reports to Regulatory Affairs. Ensures that the project teams fulfill their responsibilities in accordance with the scope of work and project plan. - Oversees and reviews work product produced by project team members. - Provides guidance and mentoring to the project team members. Ensures that projects are delivered on time, within budget, and according to requirements and expectations. - Supports the development and implementation of project budgets and tracks actual expenditures to the budget. - Coordinates and communicates project activities; produces project status reports on a timely basis, and alerts management of impediments to progress; conducts project status meetings, as appropriate. - Evaluates alternative solutions to resolve problems - Resolves obstacles to team progress; may facilitate resolution with affected parties. - Ensures that work complies with BARD policies, standards and procedures, GCP-ICH guidelines, and applicable regulations. - Manages business expectations related to project deliverables and performance metrics. Handles multiple responsibilities / projects on an ongoing basis. Interacts with internal and external project teams to assure comprehensive management of projects. Serves as the primary project contact for communication. Maintains understanding of BARD's general business functions and systems. Performs risk assessment and escalates to management if there is significant business impact. Assists in the development and implementation of standardized processes and operating procedures for conducting clinical research. Assists in employee training and mentoring activities. Job Requirements Bachelors Degree and a background in a life science, health science or related field. Minimum of 3 years of site monitoring experience. Minimum of 5-7 years of medical device / research industry project management experience. Demonstrated project and people management skills including: ability to execute successful programs within a timeline, ability to allocate resources, proven leadership skills and can motivate and guide subordinates to meet company/project objectives. Prior experience in financial management of projects preferred. Prior experience in managing, mentoring and developing staff. Ability to work with multiple divisions and prioritize work. Experience with clinical audit requirements and ability to prepare/participate in FDA audits. Expert in regulations (FDA/CFR, ICH/GCP). Excellent communication skills (oral and written). Effective public speaking skills. Detail oriented. Strong computer skills. Strong interpersonal and organizational skills. Ability to work independently, manage multiple projects and personnel in a fast paced environment. Willing to travel up to 40%. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Job Title: Sr.Clinical Project Manager Company: Catalent Pharma Solutions Location: Philadelphia, PA Description: ENTER JOB TITLE About Us Headquartered in Somerset, New Jersey, Catalent Pharma Solutions (formerly Cardinal Health, Inc., NYSE: 'CAH') is the leading provider of advanced technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 10,000 at more than 30 facilities worldwide and generates more than $1.7 billion of annual revenue. For more information, visit Catalent.com I.ESSENTIAL FUNCTIONS: This position is responsible for managing project teams and cross-functional activities related to the preparation, packaging, labeling, assembly and distribution of stability, analytical, and clinical trial materials. The individual will lead the project manager(s) and clinical coordinators responsible for accounts including potentially critical business relationships and critical cross-divisional work.     Job Requirements  II. SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES:  -Lead large-scale, multi-disciplinary project teams, comprising representatives from appropriate functions to handle intricate and complex projects related to diverse clinical studies. -Demonstrate continuing and consistent success with critical decision-making techniques and methods.  Utilize technical proficiencies both independently and in collaboration with others resulting in increased efficiency and quality standards. -Develop and propose multi-faceted service solutions to customers to achieve desired performance results. Emphasis will be placed on multi-phase studies with multiple campaigns, high complexity, and global application / distribution. -Oversee and manage the financial forecast for clinical supplies manufacturing, packaging and drug procurement on a weekly basis, ensuring that the production schedule reflects the months revenue.  Correspond with Finance personnel on timing and follow-up of billing activities. -Interact regularly with Department Managers and other personnel from various Cardinal Health PTS, Inc. divisions to increase cross-divisional communication and cooperation. Implore cooperation from other management as deemed necessary by team, department and division objectives. -Support Cardinal Health Business Development and Sales Management during meetings, trade shows, and marketing presentations of capabilities to prospective customers.  -Implement and track Key Performance Indicators (KPI’s) to measure team/departmental effectiveness and efficiencies as they pertain to the Cardinal Health organizational goals and objectives. -Manage and track the progress of individual goals and objectives of team & department personnel through KPI’s, discussions/meetings and performance evaluation. -Assist teams/department with ensuring that key project milestones in agreement with customer are achieved and that project progresses in a satisfactory and timely manner. -Manage strong communication with the customer as a support for the assigned project manager, ensuring that all developments or changes to project plan are conveyed appropriately. -Evaluate, identify, develop and implement Process Improvement Methods to increase throughput and efficiency of the clinical project management department -Manage and facilitate the development and training of Project Management staff, including Clinical Coordinators and Project Managers.  Areas of critical development include JD Edwards, Project Management, Customer Service, Negotiation, and Time Management. -Assist Director with oversight of all clinical, stability, and relevant commercial quoting and billing activities. -Assist Director with development and administration of the Clinical Project Management Department budget. -Actively participate in industry-related organizations and programs, such as trade-shows, conferences, and advanced training. -Ensure project compliance with all FDA (GMP / GCP) regulations. Implement standard operating procedures (SOPs) and training documentation. III. POSITION REQUIREMENTS  Education or Equivalent: BS in Biology/Chemistry/Pharmacy or 8-10 years relevant experience in a pharmaceutical /project management setting. Managerial experience 3-5 + years of personnel management (direct reports). Clinical Trial Materials experience preferred.    Knowledge/Skills Requirements: Familiarity with Drug Development or Package Development Process as well as knowledge of Pharmaceutical packaging market and market competitors.  Demonstrated leadership ability, exemplary communication and interpersonal skills. Computer aptitude in word processing, spreadsheet, database, and project management software. Organized, self-motivated, and goal-oriented. Physical/Mental Requirements: Walking, sitting, standing, ability to differentiate colors.    Business Environment: Office environment and some work on the production floor and in warehouse environment.  Some travel (10 – 30%) will be required. EEO: Catalent Pharma Solutions offers a competitive compensation, paid time off and benefits package including 401K and tuition reimbursement. Successful candidates must pass a background check and drug screen. We are an Equal Opportunity Employer M/F/D/V Our equal opportunity policies and affirmative action programs are designed to ensure that all applicants and employees are considered for opportunities without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, veteran status or disability except where an accommodation is unavailable and an individual’s disability is a bona fide occupational disqualification. These policies and programs cover every aspect of the employment experience: recruitment, selection, promotion, transfer, layoff, recall from layoff, compensation, access to training, benefits, education, tuition assistance, company-sponsored social and recreational activities, and termination.

Job Title: Sr. Clinical Project Manager: Global Studies, North NJ, $140k+ Company: Cornerstone Search Group, LLC Location: East Rutherford, NJ Description: Sr. Clinical Project Manager: Global Studies, North NJ, $140k+ Our client is looking for a seasoned Clinical Research professional to actively manage multiple global clinical study teams across therapeutic areas. You will manage people on a project basis and not have to be weighed down with hiring/firing responsibilities. Our client is an industry leading pharmaceutical company with an excellent reputation as an employer that takes care of their people and is rated year in and year out as a top employer to work for. Compensation is competitive and benefits are very strong. Note: All inquiries and submissions are held in strict confidence (see our privacy policy below). Position Title: Sr. Manager, Global Clinical Studies Company Description: Our client is an industry leading pharmaceutical company that has a stellar reputation. Not only do they have numerous marketed products and pipelines in multiple therapeutic areas, but they are also rated as a top company to work for by numerous large publications. Just this past year they were ranked as the Pharmaceutical Company of the Year. Location: East Rutherford, New Jersey areaAttractive features about this position and company: International Trials: Work across a number of therapeutic areas on a global level. This Company is continuing to grow an already robust Clinical Research and Development department with multiple leading products. Great location for those not only in NJ (North/East/West/Central), but also from NYC, Southern CT, or NY counties north of NYC. Easily accessible from Route 80, 46, 287, and 3 as well as the NJ Turnpike and Garden State Parkway. Firm has a strong reputation for taking care of its people. Compensation/Benefits: Base compensation will be competitive and can range from $115-$135k+. This will also include a bonus and top-tier benefits including: 100% tuition reimbursement, a generous 401(k) plan, and exceptional on-site facilities/perks including Child Care, Staff Training, Fitness Center, etc. Responsibilities, Challenges, Expectations and Deliverables for this position: In a nutshell, you will be responsible for leading multiple global study teams. This is a strategy-based position where you oversee Clinical Research Managers who handle the day-to-day responsibilities. Proactively participate in leading teams as well as any process improvement plans. Manage the overall strategic goals/deliverables on a number of different studies/therapeutic areas. Involvement in ensuring that all resources and study related materials are available on all projects. Ensure that all site feedback and/or problems are handled in a timely and professional manner. Experiences, Skills, Accomplishments and Qualities Desired: BS/BA degree in a scientific or life sciences. Advanced degree is preferred. 7-10 years of clinical research experience. They will consider someone with a few years of true study management responsibilities. Direct report/people management experience is not required. Multiple therapeutic areas acceptable. Must have exceptional leadership skills. Must be able to see the bigger picture (ie. strategic perspective, global orientation, collaborative thought process, etc.) Other Opportunities Our firm specializes in Pharmaceutical recruiting for firms located in NJ, NYC, and the surrounding areas. In addition to this opportunity, we are helping many of our other clients, located in Central NJ, Northern NJ, and NYC, on other CRA, SR. CRA and Clinical Project Management full time and consulting positions. For description of those opportunities, please visit our site www.cornerstonesg.com. Cornerstone’s Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact: Thomas Fascia Manager, Specialized Pharmaceutical Practice Register to View Cornerstone Search Group, LLC 9 Sylvan Way Parsippany, NJ 07054 P Register to View x17 F Register to View Web/URL: www.cornerstonesg.com About Cornerstone Search Group, LLC Cornerstone Search Group is a specialty pharmaceutical recruiting firm located in the heart of New Jersey's Pharmaceutical Corridor. We help our clients hire experienced pharmaceutical professionals from the Staff through Management (VP/Director) levels for Full-Time and Contract positions. We provide our professional recruiting services on a Contingency, Retingency, or Retained basis to best suit the hiring needs of our clients. RECRUITING FROM STAFF THROUGH MANAGEMENT LEVELS IN: - Biostatistics and SAS Programming - Clinical Operations (CRAs, Project Managers, Management) - Clinical Research - Data Management / Clinical Programming - Drug Information - Drug Safety - Human Resources - Information Technology - Marketing / Market Research - Medical Directors - Medical Science Liaison - Medical Writing - Product Management - QA/QC - Regulatory Affairs Building better companies. Building better careers.®

Job Title: Clinical Project Manager Company: PharmaceuticalCrossing Location: Columbus, OH Description: Clinical Project ManagerRequirements: A BA/BS is preferred. A Life Science degree or BSN is preferred. 8-9 years of experience in a related field is required. 6 years of experience in pharmaceutical clinical research is preferred. Protocol execution experience is required. Site monitoring experience and management experience is preferred. Proficient in the areas of Clinical Trial Planning, Execution & Management, Drug Development Knowledge, Scientific Knowledge and Technical Communication. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management. Willingness to Travel.For further information, please visit us online at http://www.pharmaceuticalcrossing.com Please send your resume to PharmaceuticalCrossing at Register to View Apply Now There will be charge of $29.95 per month (or a lower monthly rate based on agreement length) after your 7 day FREE Trial to use our service.

Job Title: Sr. Clinical Project Manager Company: Catalent Location: Philadelphia, PA Description: COMPANY OVERVIEWCatalent is a global leader in drug-delivery technologies, contract manufacturing, packaging and product launch services. With seven decades of experience and over 1500 patents and patent applications, Catalent brings its customers innovative expertise throughout a drug’s development, launch and entire lifecycle.Catalent Pharma Solutions was created in April 2007 from the Pharmaceutical Technologies and Services segment of Cardinal Health. Catalent has nearly 75 years of experience in serving pharmaceutical and consumer health companies around the globe, and nearly 20 years of experience in serving the biotechnology industry. About Us Headquartered in Somerset, New Jersey, Catalent Pharma Solutions is the leading provider of advanced technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. Catalent applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 10,000 at more than 30 facilities worldwide and generates more than $1.7 billion of annual revenue. For more information, visit Catalent.com  I.  Department Overview: This position is responsible for managing project teams and cross-functional activities related to the preparation, packaging, labeling, assembly and distribution of stability, analytical, and clinical trial materials. The individual will lead the project manager(s) and clinical coordinators responsible for accounts including potentially critical business relationships and critical cross-divisional work.   II.  Specific Duties, Activities, and Responsibilities: ·         Lead large-scale, multi-disciplinary project teams, comprising representatives from appropriate functions to handle intricate and complex projects related to diverse clinical studies.·         Demonstrate continuing and consistent success with critical decision-making techniques and methods.  Utilize technical proficiencies both independently and in collaboration with others resulting in increased efficiency and quality standards.·         Develop and propose multi-faceted service solutions to customers to achieve desired performance results. Emphasis will be placed on multi-phase studies with multiple campaigns, high complexity, and global application / distribution.·         Oversee and manage the financial forecast for clinical supplies manufacturing, packaging and drug procurement on a weekly basis, ensuring that the production schedule reflects the months revenue.  Correspond with Finance personnel on timing and follow-up of billing activities.·         Interact regularly with Department Managers and other personnel from various Catalent divisions to increase cross-divisional communication and cooperation. Implore cooperation from other management as deemed necessary by team, department and division objectives.·         Support Catalent Business Development and Sales Management during meetings, trade shows, and marketing presentations of capabilities to prospective customers.  ·         Implement and track Key Performance Indicators (KPI’s) to measure team/departmental effectiveness and efficiencies as they pertain to the Catalent organizational goals and objectives.·         Manage and track the progress of individual goals and objectives of team & department personnel through KPI’s, discussions/meetings and performance evaluation.·         Assist teams/department with ensuring that key project milestones in agreement with customer are achieved and that project progresses in a satisfactory and timely manner.·         Manage strong communication with the customer as a support for the assigned project manager, ensuring that all developments or changes to project plan are conveyed appropriately.·         Evaluate, identify, develop and implement Process Improvement Methods to increase throughput and efficiency of the clinical project management department  II. Specific Duties, Activities, and Responsibilities: Continued ·         Manage and facilitate the development and training of Project Management staff, including Clinical Coordinators and Project Managers.  Areas of critical development include JD Edwards, Project Management, Customer Service, Negotiation, and Time Management.·         Assist Director with oversight of all clinical, stability, and relevant commercial quoting and billing activities. ·         Assist Director with development and administration of the Clinical Project Management Department budget.·         Actively participate in industry-related organizations and programs, such as trade-shows, conferences, and advanced training.·         Ensure project compliance with all FDA (GMP / GCP) regulations. Implement standard operating procedures (SOPs) and training documentation. III.  Position Requirements: Education or Equivalent: BS in Biology/Chemistry/Pharmacy or 8-10 years relevant experience in a pharmaceutical /project management setting. Managerial experience 3-5 + years of personnel management (direct reports). Clinical Trial Materials experience preferred. Knowledge/Skills Requirements: Familiarity with Drug Development or Package Development Process as well as knowledge of Pharmaceutical packaging market and market competitors.  Demonstrated leadership ability, exemplary communication and interpersonal skills. Computer aptitude in word processing, spreadsheet, database, and project management software. Organized, self-motivated, and goal-oriented.Physical/Mental Requirements: Walking, sitting, standing, ability to differentiate colors. Business Environment:Office environment and some work on the production floor and in warehouse environment.  Some travel (10 – 30%) will be required.      EEO Catalent Pharma Solutions offers a competitive compensation, paid time off and benefits package including 401K and tuition reimbursement. Successful candidates must pass a background check and drug screen. We are an Equal Opportunity Employer M/F/D/V Our equal opportunity policies and affirmative action programs are designed to ensure that all applicants and employees are considered for opportunities without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, veteran status or disability except where an accommodation is unavailable and an individual’s disability is a bona fide occupational disqualification. These policies and programs cover every aspect of the employment experience: recruitment, selection, promotion, transfer, layoff, recall from layoff, compensation, access to training, benefits, education, tuition assistance, company-sponsored social and recreational activities, and termination.

Job Title: Clinical Project Manager Company: Aerotek Scientific Location: Kenilworth, NJ Description: One of the leading pharmaceutical companies located in NJ is seeking a seasoned Clinical Project Manager to join their Infectious Disease and Dermatology department. Brief Summary of Position: The Clinical Project Manager (CPM) in Global Clinical Trial Management (GCTM) will function as a Study Team Leader by organizing and managing all operational aspects of the study from conception to submission while ensuring adherence to timelines. The CPM works closely with the therapy area project physician/project director in supporting the project physician with presentation of various study level information. The CPM contributes to the clinical development team and is a core team member. The CPM will manage critical study issues such as budgeting, and drug supply, enrollment status and study progress. The CPM interacts with CROs and vendors as needed. The CPM will also proactively address risk management through contingency planning. Major activities will include but are not limited to the following: Coordinate with all relevant groups to develop clinical protocol timelines. Contribute to building and managing protocol level budgets. Participate in development of operational plans for a clinical study or multiple clinical studies within a development program. Manage the progress of project(s) and ensure adherence to intended timelines including enrollment, clinical supplies, and data delivery, as well as Clinical Study Report (CSR) authoring and review. Oversee study reporting which will be used in both internal and external communications. Identify issues that may impact the overall project plan and initiate contingency plans as appropriate. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management. Work with Regulatory Affairs, vendors and Country Operations to establish appropriate study processes to ensure compliance with guidances and regulations. Review resource requirements and may supervise direct reports. May perform co-monitoring as necessary. Requirement: BA/BS; Life Science degree or BSN Dermatology/Anti-Fungal/Infectious Disease therapy area experience is preferred Overall 8-9 years experience required. Minimum 6 years experience in pharmaceutical clinical research. Protocol execution experience required. Site monitoring experience and management experience preferred. The CPM must be proficient in the areas of Clinical Trial Planning, Execution & Management, Drug Development Knowledge, Scientific Knowledge and Technical Communication. The CPM must have prior experience in overseeing/managing CRO activities The CPM should have prior experience in managing direct reports Ability to travel is required for this position Experience with Microsoft Project is a plus Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers. CompetenciesDesired:Protocol execution experience, Site monitoring experience and management, Clinical Trial Planning, Execution & Management, Drug Development Knowledge, Scientific Knowledge and Technical Communication, overseeing/managing CRO activities, managing direct reports Contact Information Contact: Blough,Michelle L --> Email this job Email: Send Email Now Address: US-NJ-Kenilworth Phone: Register to View Fax: Register to View Reference Code: 1831717 Click here to see all

Job Title: Clinical Research Manager Company: SIR Foundation Location: Fairfax, VA Description: Would you like to work with innovative, enthusiastic, and collegial physician leaders who are developing the most cutting edge, 21st century patient therapies in medicine?  Would you like to be part of a team that is building tomorrow's physician practices today?   The Society of Interventional Radiology (SIR) is a national organization of physicians, scientists, and allied health professionals dedicated to improving public health through disease management and minimally invasive, image-guided therapeutic interventions.  Today, SIR continues to maintain steady membership growth with more than 4,000 physician and allied health care members.  SIR currently has an opening for a Clinical Research Manager.   In this position, you will be responsible for the management of the clinical research and education divisions of the SIR Foundation. These are growth areas for the Foundation. Thus, the position requires an enthusiastic self-starter, eager to take the lead on establishing new programs and infusing new ideas into established projects. The ideal candidate will have demonstrated clinical research project management experience, including success in increasing site/investigator participation in clinical trials.   The ideal candidate will have a master's degree with 3+ years of related experience in clinical research. The candidate will also have the following qualifications and experience:   QUALIFICATIONS   Excellent project management skills Ability to work well independently and proactively Excellent written and oral communication skills Superior organizational skills and strong attention to detail Ability to appropriately interact at various levels, from junior staff through to senior management, within the organization, and as well with physician volunteers in a member-service environment.   EDUCATION and/or EXPERIENCE Bachelor of Science degree required; master's degree in relevant area preferred Minimum of 3 years experience in clinical and/or medical research Clinical trials administration experience highly desired Experience with associations highly desired Experience with Microsoft Access, PowerPoint, Excel and Word   CERTIFICATES, LICENSES, REGISTRATIONS Certification in clinical trials administration is preferred but not required   SIR offers a competitive salary and an excellent benefits package.  To be considered for this position, email your resume and cover letter (including salary requirements) to:  Register to View   Please be sure to put "Clinical Research Manager" in the subject line.  EOE.