Clinical Project Manager Jobs

Job Title: CLINICAL RESEARCH MANAGER Company: General Electric Company Location: Wauwatosa, WI Description: Build and enhance GE Healthcare Technologies' regional profile, standing and relationships in the clinical radiology and cardiology research field by driving on-site clinical research, supporting professional society meetings and participating in and developing strategic/research account relationships. Work with GE Interventional Management, identify key regional customer though leaders and formulate target strategies to develop new scientific research and/or advisory relationships. Work with the Advance Applications team to define, develop and drive advanced study protocols, data analysis and publication with clinical researchers. Coordinate upstream and downstream marketing to translate research results into competitive sales tools. Develop new application for GE Healthcare' s diagnostic imaging technologies in coordination with research partners. Qualifications/Requirements Master’s degree in Imaging/Medical Physics, Biology, Biomedical Science, Biological Sciences, or Perfusion Technology required. One year of experience as a Clinical Research Manager, Medical Research Scientist, Medical Intern, or Research Assistant is acceptable. One year of experience must include some experience with Clinical Research/Work in Radiology and/or Cardiology.

Job Title: Clinical Project Manager IV 168265 (NCI) Company: SAIC Location: Rockville, MD Description: TO BE CONSIDERED FOR THIS POSITION, QUALIFIED CANDIDATES SHOULD E-MAIL RESUMES TO THE STEVENSON GROUP AT THE FOLLOWING E-MAIL ADDRESS: Register to View This is a senior level, supervisory position with responsibility for developing and directing the planning, execution and operations of a Project Management Office (PMO) that supports the National Cancer Institute’s Experimental Therapeutics program (NExT). The Director coordinates, directs and reviews the work of Project Managers and their supporting Project Coordinators. The Director will serve as the point of contact between the PMO and NCI senior management to form, manage and coordinate global, cross-functional project teams to develop novel targeted agents for cancer (Chemical Biology Consortium (CBC) discovery pipeline, the Developmental Therapeutics Program, and first-in-human Phase 0/I trials). The position requires a team-oriented leader with both executive skills and project management knowledge and experience to plan, organize, execute, assess and report on assigned program objectives from the client, and judge alignment with NCI goals and strategic plans. The position requires excellent communication with NCI officials and SAIC-F senior management to evaluate and report on status of high-priority areas of the NExT Discovery and Development Committees, facilitate reviews of potential external collaborators with new drug candidates, and transmit NExT information about Phase 0/I or CBC activities, pipeline priorities and research interests to the extramural community. The Director will be responsible for the conduct and quality of all PMO operations, including: identification of critical paths, resource restrictions and other risks, decision points, and project milestones; development of contingency plans and solutions; develop project templates and processes using project management tools to optimize PMO performance and provide maximum value to the client; monitor progress against plans and the status of key deliverables; development and implementation of a research quality system consisting of policies, standards, documentation and training methods; and hiring, development, training and appraisal of PMO staff. REQUIRED SKILLS: Possession of a Doctoral degree from an accredited college/university in a field related to developmental therapeutics, oncology, biomedical research and/or clinical trials. Candidates with a Master’s degree in one of these areas will be considered if they have two (2) additional years of related experience in lieu of the Doctoral degree. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. The job experience requirements include a minimum of ten (10) years of increasingly responsible and responsive experience, achievement and organizational visibility in project management in developmental therapeutics, including at least eight (8) years of experience providing project management to multiple concurrent drug developmental/translational/early clinical trial projects, wherein some of these projects involved management of the preclinical to clinical transition. At least three (3) years of experience managing a team of project managers is also required. Key evaluation factors include demonstrated ability to drive projects to completion by proactively coordinating the efforts of external and internal partners, within reasonable budgetary restrictions, and in compliance with deadlines and regulatory and client requirements; ability to work in a drug development/research setting both independently and within a team of technical specialists and project leaders; ability to apply working knowledge of drug development to critique and evaluate scientific and supply chain status relative to timetables to assess overall project timeliness and risks; and excellent communication skills to be able to develop project management staff to require levels of independence. Evidence of ability to judge, organize, prioritize and assign multiple tasks/projects with simultaneous orientation to detail and vision to understand the high-level interrelationships between the organization and its NCI client. This position is subject to obtaining a Public Trust Clearance. DESIRED SKILLS: The ideal candidate will have at least 3 years post-project management experience as a client/user of project management, in a position of dependency upon a Project Management Office to effectively manage achievement of milestones for a large organizational mission. Knowledge of, and experience with, project management of cancer drug discovery and/or high through-put screening (HTS) campaigns is preferred. Project Management Professional (PMP) certification also a plus. Familiarity with pharmacology/toxicology, cGMP manufacturing of small molecules, regulatory processes/strategies, operational and/or product quality management and/or clinical trials management also a plus.

Job Title: Clinical Project Manager II 168784 (NCI) Company: SAIC Location: Rockville, MD Description: To discuss this opportunity with members of our team, please join us at one of our upcoming open houses! Tuesday, March 9th from 3:30pm to 7:30pm at the Hampton Inn, 5311 Buckeystown Pike, Frederick, MD or Thursday, March 18th from 3:30pm to 7:30pm at the Bethesda North Marriott, 5701 Marinelli Road, Bethesda, MD. THIS POSITION IS CONTINGENT UPON AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) FUNDING. The Clinical Monitoring Research Program (CMRP) provides comprehensive programmatic/project and procurement management support to the NCI cancer Human Biobank (caHUB). The Clinical Project Manager II is responsible for managing the comprehensive and programmatic activities associated with support to the caHUB efforts of the Office of the Biorepositories and Biospecimen Research (OBBR) initiatives. Serves as the lead for project and programmatic planning, research subcontracting, analysis, correspondence control, communication, and liaison activities for OBBR funded projects, specifically with regards to those that reside within the OBBR Tissue Source Site Interface Team. Specific subcontracts will include those related to the acquisition of tumor and normal tissues. Plans and implements program strategies and coordinates the OBBR Operations Team that supports overall project functions for the centralized quality assurance, molecular validation, storage and distribution of high quality biospecimens, as well as the comprehensive databank that incorporates clinical data, specimen collection/handling data, and molecular analysis data. Collaborates with the NCI Office of the Director, the NCI Project Officer and subcontracted technical experts/organizations to assure success of the program’s mission and goals. Serves as the contracting officer's technical representative (COTR) for the comprehensive solicitation, review, pre- and post award activities on a variety of procurement activities and serves as the main contact representing the NCI to the subcontract organizations. Prepares progress and program reports, special reports, and coordinates planning and budget documents. Coordinates meetings and site visits amongst various groups including subcontractors/awardees and NCI officials. Interfaces with other government officials, both scientific and administrative. Coordinates programmatic responses and preparation of cost estimates. This position is located in Rockville, Maryland. REQUIRED SKILLS: Possession of a Bachelors degree from an accredited college/university in a field related to biomedical research/clinical trials/health or four (4) years related experience in lieu of degree. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to the education requirements, a minimum of eight (8) years of progressively responsible relevant experience in clinical research including a minimum of three (3) years directly managing multiple concurrent clinical projects. Clinical research experience includes clinical trials and biospecimen acquisition, storage, and data management, interfacing with medical staff, research subcontracts work, and comprehensive project management. Must have experience that demonstrates project management skills that include coordinating support functions, prioritizing multiple tasks/projects and providing direction and team leadership on complex projects involving multiple disciplines. At least one (1) year experience managing a team of project managers and/or coordinators is also required. Proficiency in Microsoft Excel, Word, and PowerPoint. Demonstrated effective track record of project management leadership and application. Demonstrated ability to drive projects through to completion by proactively coordinating the efforts of external and internal partners, within reasonable budgetary restrictions, and in compliance with deadlines and regulatory/company requirements. Ability to work both independently and within a team. Detail-oriented and strong organizational skills with the ability to prioritize multiple tasks/projects. This position is subject to obtaining a Public Trust Clearance. DESIRED SKILLS: Experience in new program development involving project management and research subcontract development in the biotechnology, pharmaceutical, or other healthcare-related field. Project Management Professional (PMP) certification a plus. Masters degree in the life sciences and/or certifications in project management preferred.

Job Title: Clinical Project Manager Company: MedFocus Location: Cambridge, MA Description: .ugDivBody_hj .ugFrame_hj .ugColWrap_hj .ugHeader_hj .ugHeadBot_hj .ugHeadBot_hj a:link .ugHeadBot_hj a:visited .ugHeadBot_hj a:hover, active .ugSeeLink_hj .ugLeftWrap_hj .ugLeftCol_hj .ugJobTitleLeft_hj .ugJobTitleLeft1_hj .ugLTable_hj .ugLHead_hj .ugLText_hj .ugMap_hj .ugMapplace_hj .ugRightWrap_hj .ugRightCol_hj .ugROver_hj .ugLeftLinks_hj a:link .ugBold_hj .ugRTitle1_hj .ugRtext_hj .ugFooter_hj .ugBanner_hj See all jobs at this company Job overview Company:  MedFocus Job Id:  Register to View Job Title:  Clinical Project Manager Location:  Cambridge, MA Job Category:  Pharmaceutical/Biotech Position Type:  Full-Time, Contract Education:  Bachelor of Science Experience:  2-5 Years Experience Company overview Since 1993, MedFocus has succeeded in meeting the contract staffing needs of our consultants and clients faster and more effectively than our competition through "specialized" recruiting exclusively in the pharmaceutical arena. By staying focused, MedFocus has become the firm of choice for both client companies and our consultant job seekers. MedFocus is headquartered in Chicago, IL and has offices in Philadelphia, PA and San Francisco, CA. Learn More about MedFocus Company Website About Us Clinical Project Manager Job Description CLINICAL PROJECT MANAGERCOMPANY INFO:MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.Our client is dedicated to making a major positive impact on the lives of people with serious diseases and is seeking to add a Clinical Project Manager to their team.RESPONSIBILITIES:• Manage the activities of vendors, including clinical services, data management, biostatistical services, and central laboratory services • Estimate and manage the clinical supplies needed for the conduct of clinical trials • Develop clinical monitoring plans and establish study monitoring priorities • Assists in the development and writing of study protocols, study plans, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA). • Interact with investigators and thought leaders for protocol development, presentations and publications. • Address and seek resolution of administrative issues with investigational sites and/or CROs• Manage study sites and train clinical site staff to ensure protocol and regulatory compliance. • Responsible for clinical site budget development • May be responsible for ensuring SOP and regulatory compliance of staff • Coordinate and participate in investigator meetings.QUALIFICATIONS:• Bachelor's degree in a relevant scientific discipline or equivalent. • 5+ years of relevant clinical PM experience in the pharmaceutical industry or equivalent. • Knowledge of GCP and ICH guidelines required. • Proficiency in the implementation, monitoring, and management of clinical trials • Demonstrated managerial and supervisory skills • Excellent communication and interpersonal skills. Detail oriented. • Able to problem solve and use good judgment. • Able to work within a team and work with general instructions. • Proficiency with MS Word, Excel, Outlook, and PowerPoint. Microsoft Project skills preferred.MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

Job Title: Clinical Research Manager, Devices:Exciting International Company, NJ/NYC area Company: Cornerstone Search Group, LLC Location: Jersey City, NJ Description: Clinical Research Manager, Devices:Exciting International Company, NJ/NYC area Our client, a smaller drug-device company, is looking for an experienced Clinical Research and Operations professional to come in and manage Device Trials (domestic and international).  You will work cross-functionally with global trial management  and will report directly to the Head of US Operations.  They are very conveniently located in the NJ/NYC area.  Compensation is competitive.    Note: All inquiries and submissions are held in strict confidence (see our privacy policy below).   Position Title: Clinical Research Manager Company Description: Our client is a growing drug-device company with offices in both the US and EU.  They have globally marketed products and have a partnership with a top 5 pharmaceutical company.     Location: Jersey City, New Jersey areaAttractive features about this position and company: Visible Opportunity: You will report directly to the Head of US Operations.    Growing Company: Our client has marketed products and is looking into multiple indications.  They also have a strong pipeline.     Great Location: Located in NJ/NYC.  Commutable from Northern/Central New Jersey as well as New York City. Compensation/Benefits: Total compensation (base+bonus) can be very competitive and also includes benefits.Challenges, Expectations and Deliverables:The Clinical Research Manager will be responsible for the planning, execution and management of clinical trials and the implementation of agreed upon strategies for the clinical projects within pre-specified timelines and budgets. This includes:Acting as primary contact for study team members and vendorsProactively follow up on study progressEvaluation and selection of investigatorsAssist with preparation of protocol, informed consent, IDEs, CRFs, monitoring plan, etcForecast and ensure adequate suppliesNegotiate contracts and budgetsAnticipate and indentifying potential problems and implementing corrective actionsInterface with other departments to ensure that clinical activities are in line with overall strategic goalsWork closely with marketing regarding product usage, clinical needs and feedback from investigative sites  Requirements:Master’s or Bachelor's Degree with an emphasis in health sciences.4-8 years of pharmaceutical experience, including at least 4 years of clinical development experience.CRO Management experience is required. 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 FasciaDirector, Specialized Pharmaceutical Practice Register to View  Cornerstone Search Group, LLC6 Campus DriveParsippany, NJ 07054P Register to View x17F Register to View Web/URL: www.cornerstonesg.com About Cornerstone Search Group, LLCCornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets. Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates. Building better companies.  Building better careers.® Other OpportunitiesCornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and  Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist.  Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.

Job Title: Project Manager- Clinical Company: Catalent Pharma Solutions Location: Baltimore, MD Description: id="tms_job_224">Project Manager- ClinicalJob Code :224Division :Catalent Pharma Solutions Packaging ServicesJob Title :Project Manager- ClinicalJob Type :Full-Time EmployeeShift/Hours :First Shift (Day)Location :Philadelphia PA US 19114Category :Biotech/R&D/ScienceCareer Level :Experienced (Non-Manager)Education :Bachelor's Degree% of Travel Required :20-30%Offer Relocation :NoJob Description :Basic Function:· This position is responsible for leading project development teams and management of cross-functional activities related to the preparation, packaging, labeling, assembly and distribution of stability, analytical, and clinical trial materialsSPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES:Work on complex projects related to diverse clinical studies where analysis of data requires evaluation of both material and intangible factors from numerous sources. Exercise critical decision-making techniques and methods. Demonstrate success in technical proficiency both independently and in collaboration with others.Lead multi-disciplinary project teams, comprising representatives from appropriate functions.Implore cooperation from support services personnel as deemed necessary by team and project objectives.Identify and interpret customer needs using comprehensive assessment tools to drive job quotation process in conjunction with Sales personnel.Develop and propose multi-faceted service solutions to customers to achieve desired performance results.Develop and maintain project plans through utilization of Project Management tools such as Gantt charts, MS Project software, critical path development, and resource management.Ensure 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 main point of contact, ensuring that all developments or changes to project plan are conveyed appropriately.Correspond with Finance personnel and assist in follow-up of billing activities.Interact with Project / Development Managers and other personnel from various Catalent divisions on cross-division initiatives and projects.Ensure project compliance with all FDA (GMP / GCP) regulations. Implement standard operating procedures (SOPs) and training documentation.Job Requirements :Education: BS in Biology/Chemistry/Pharmacy or relevant discipline.Experience: 2 5 years relevant experience in pharmaceutical / product development and project management; customer-driven project management in a GMP setting preferred.Knowledge/Skills: Familiarity with Drug Development or Package Development Process. Demonstrated leadership ability, excellent communication and interpersonal skills. Computer aptitude in word processing, spreadsheet, database, and project management software. Organized, self-motivated, and goal-oriented.

Job Title: Clinical Project Manager - PHARMA ONLY Company: Alternative Resources Company Location: Tarrytown, NY Description: Clinical Project Manager Summary: The Clinical Project Manager (CPM) is responsible for leadership of the clinical project team (of assigned Clinical Research Associates and Clinical Research Assistants); development of the comprehensive project plan; detailed timeline and milestone management; and all vendor management (including central laboratories, Contract Research Organizations etc.). The CPM is charged to take a leadership role in the maintenance of Clinical Operations standards and integrate Good Clinical Practice and best organizational practices into the overall drug development plan. Essential Duties and Responsibilities include the following. Other duties may be assigned.: •Responsible for overall project planning and execution; •Oversee daily activities of assigned staff and quality of deliverables; •Develop and generate necessary materials for clinical trial implementation and conduct; •Oversee Request for Proposal (RFP) process with vendors and contracts management with vendors. •Assist with the development of clinical protocols, amendments, Informed Consents for specified countries, CRF and source document design, protocol specific training documentation, administrative letters, IND safety reports and other written clinical documents; •Responsible for overall project timeline management and tracking. •Establish and maintain productive working relationships with vendors, clinical investigators, and all appropriate clinical site study staff. •Oversee data collection and respond to questions received from clinical site study staff regarding the protocol and any other study related issues. •Provide and track important safety information to required parties i.e. Director of Safety, Chief Medical Officer, Data Safety Monitoring Board and safety vendor, if applicable •Ensure that protocol/project training (on-site and Investigator Meeting) for Investigators, Study Coordinators, Monitors and other key study personnel is conducted and appropriately documented as per SOPs. •Responsible for the overall management of site monitoring and associated documentation from study initiation through close-out to ensure compliance with regulatory requirements and Good Clinical Practice. •Responsible for the overall management of the project Trial Master File and provide ongoing guidance to •Ensure that site/contract monitors or other Contract Research Organizations (CROs) are managed according to the project needs. •Responsible for the development and negotiation of study specific budgets for study centers. •Participate in negotiation and administration of contracts/payments to study centers. •Responsible for on-site monitoring of the project for a minimum of one clinical site. Quarterly visitation to sites to monitor compliance with the protocol, provide mentoring, and ensure adequate training and monitoring is in place. •Participation in various departmental/ project team meetings. •Participate in the review and development for Clinical Standard Operating Procedures. •Willingness to work on Departmental/Corporate initiatives as requested. Supervisory Responsibilities: Functional management of Clinical Research Associates and Clinical Research Assistant(s) assigned to the project. Functional management of all vendor services for the project. Education and Experience: •B.S. in a scientific or health-related field is required. Master's degree in a scientific or health-related field is preferred. •Minimum of five years of general clinical research experience, including on-site monitoring experience. •Must have a minimum of two years of experience in the management of clinical trials as a project manager at a pharmaceutical/biotech company or CRO. •Excellent interpersonal and communication (oral and written) skills are required. In addition, candidate must be organized with excellent attention to detail. •Advanced understanding of GCPs, FDA regulations and ICH guidelines is required. Therapeutic experience and knowledge of Multiple Sclerosis a plus. •Proficiency in computer programs (Microsoft Office: Word, Excel, and PowerPoint) •Willingness and ability to travel. Physical Demands: This position requires approximately 30% travel. Debra Pohl President, Pharmaceutical Recruitment Alternative Resources Company Register to View

Job Title: Clinical Project Manager III 168144 (NCI) Company: SAIC Location: Rockville, MD Description: This is a senior level position with supervisory responsibility for directing and managing the project management personnel and activities of the Project Management Office (PMO), which supports the National Cancer Institute’s Experimental Therapeutics program (NExT) in developing novel targeted agents for cancer that meet unmet medical needs (Chemical Biology Consortium (CBC) discovery pipeline, the Developmental Therapeutics Program, and first-in-human Phase 0/I trials that include clinical pharmacodynamic endpoints). The major responsibilities of the Supervisory Project Manager are (i) plan, assign, schedule, monitor, review, approve, coordinate and evaluate tasks and responsibilities of project managers and project coordinators to achieve effective and efficient project management support of the NExT program, especially to assist the NCI in the formation, function and coordination of cross-functional project teams; (ii) lead the effort to identify and implement customized project management best practices, principles and tools that will provide benefit and value to the NExT program and the PMO itself; (iii) assess operational and infrastructure needs of the project management group, determine how and when to integrate these into the overall operations of the PMO in coordination with the NCI, and make actionable recommendations to the PMO Director regarding implementation; (iv) as a member of the PMO leadership team, provide valuable analysis, advice and ideas to the Director; (v) lead the recruitment, development and training efforts to fully develop the project management unit; and (vi) serve as the point of contact in the PMO for direct communication and interaction with NCI senior management about project management strategy, tactics, requirements and activities. REQUIRED SKILLS: Possession of a Masters Degree from an accredited college/university in a field related to developmental therapeutics, oncology, biomedical research and/or clinical trials, or six (6) years related experience in lieu of a degree. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to education, requirements include a minimum of ten (10) years increasingly responsible and responsive experience, achievement and organizational support of developmental therapeutics with project management/coordination, including at least six (6) years of experience providing project management to multiple concurrent projects, wherein some of these projects involved management of the preclinical to clinical transition. At least four (4) years of experience managing and evaluating project managers is also required. The position requires a team-oriented leader with executive skills; dynamic, flexible and adaptable project management knowledge; supervisory experience with direct reports; and enthusiasm for creating unique solutions that meet client needs. The position requires excellent verbal and written communication skills with internal and external customers, in the form of both planned presentations and spontaneous discussions. This position also requires the ability to work in a drug development/research setting within a team of technical specialists, project leaders and program leaders, and apply working knowledge of drug development to critique and evaluate scientific and supply chain status relative to project timelines and risks. It requires excellent supervisory skills to develop project management staff and to judge, organize, prioritize and assign their tasks to achieve alignment with client expectations and high-level interrelationships. This position is subject to obtaining a Public Trust Clearance. DESIRED SKILLS: Will also have experience as a client/user of project management, or will have been in a position of dependency upon a Project Management Office, to effectively conduct complex projects in a large organization. A Masters degree and/or professional certification in Management is a plus. Knowledge of, and experience with, project management applied to cancer drug discovery/development, molecular oncology or validation of therapeutic drug targets are preferred. Familiarity with pharmacology/toxicology, cGMP manufacturing of small molecules, regulatory requirements, quality management and/or clinical trials management, and software applications a plus.