Clinical Trial Manager Jobs

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 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 Project Manager Company: ClinForce Location: Kenilworth, NJ Description: Minimum 6 years experience in pharmaceutical clinical research; Protocol execution experience required; Site monitoring experience and management experience preferred; Must be proficient in the areas of Clinical Trial Planning, Execution & Management, Drug Development Knowledge, Scientific Knowledge and Technical Communications; Must have prior experience in overseeing/managing CRO activities; Should have prior experience in managing direct reports; Ability to travel is required for this position; Experience with Microsoft Project is a plus; Will report to the Clinical Associate Director for IDD Education/Degree:

Job Title: Clinical Project Manager Company: Smith Hanley Consulting Group Location: Kenilworth, NJ Description: Smith Hanley is seeking a Clinical Project Manager in the NJ area. The successful candidate 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.   When you work for Smith Hanley Consulting Group, you are partnering with a leader in clinical trials and scientific staffing.  For over two decades, we have built solid and successful relationships with top pharmaceutical companies across the USA.  Our recruiters are committed to finding you the perfect job, allowing you to build and diversify your experience.  We are dedicated to understanding your skills and career goals inside out.    Smith Hanley Consulting offers competitive salaries and immediate medical/dental coverage.  In addition, our benefit package includes life insurance, long-term disability and a 401(k) retirement plan with an employer match.  For out of state contracts, we provide relocation assistance and per diem.  We even pay for work Visas and offer Green Card sponsorships.  So come join the clinical consultant’s employer of choice.  What are you waiting for?  Apply today!  Job Requirements CLINICAL PROJECT MANAGER (1ABD) - BA/BS; Life Science degree or BSN preferred Dermatology/Anti-Fungal/Infectious Disease therapy area experience is preferred Overall 8-9 years experience required in a related field.   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

Job Title: Clinical Project Manager Company: Schering-Plough Location: Kenilworth, NJ Description: Shape Your Future?And Ours. Schering-Plough is an innovation-driven, science-centered global health care company. Through our own biopharmaceutical research and collaborations with partners, we create therapies that help save and improve lives around the world. We apply our research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by our colleagues around the world. Clinical Project Manager Requisition Number: 23520BR Develop and coordinate the operational plans for a clinical study or multiple clinical studies within a development program. Lead Study Teams. Manage the progress of projects(s) and ensure adherence to intended timelines including enrollment, clinical supplies, and data delivery, as well as CSR authoring and review. Manage planning, distribution, and proper labeling of clinical supplies globally on a program or protocol level. Coordinate with all relevant groups to develop clinical project timelines. Disseminate clinical project communications to all functional groups as appropriate. Develop protocol level clinical study budgets. Review site recruitment, initiation and patient enrollment progress and review and act on trending reports. Develop, with Clinical Scientist, all operational contingency plans and trigger points for these contingencies. Work with appropriate functional groups to initiate corrective action plans that may fall outside the scope of the contingency plans. Collaborate with the Clinical Operations Associate Director (COAD) to ensure consistent vendor selection and management across protocols. Collaborate with Clinical Scientist (CS) and Physician/Director on SAE reconciliation. May have line management responsibility for Clinical Project Specialists (CPS) and Clinical Trial Coordinators (CTC). May perform co-monitoring as necessary.

Job Title: Clinical Project Manager Company: Kika Medical Location: Boston, MA Description:  Are you an enterprising individual looking for an exciting opportunity to apply your skills in making a difference to the bottom line?  Do you crave autonomy in managing your work to satisfy your customers?  If you answered yes to these questions then KIKA Medical is the culture for you. KIKA offers proprietary software and professional services to collect, transmit, review, store, analyze and combine clinical trial information through the Internet.  Our clients are the pharmaceutical, biotechnology and medical device industries as well as research organizations.  For more information please checkout our website at: www.kikamedical.com. Qualifications Team and Project Management·         3 to 5 years of project management experience.·         Candidate will have facilitator, teamwork and project management skills.·         Strong interpersonal, communications, presentation and negotiation skills.·         Ability to work well independently or on a team.·         Strong organizational skills, with a track record of managing multiple tasks effectively. Change Management·         Demonstrated ability for rapid on-the-job learning, with excellent analytical and problem-solving skills.·         Ability to learn and apply new technology, and to quickly formulate conceptual designs.·         Ability to work well in a fast paced team environment. Clinical and Technology Skills·         Knowledge of clinical trial process and an understanding of application design and development processes.·         Development of clinical trial protocols and CRFs·         Design and development of electronic CRFs·         Clinical trial management·         Experience with lifecycle development and user requirements methodologies.·         Track record of success in designing and delivering full life-cycle systems projects. Industry experience·         At least two years experience of clinical trials for medical devices or pharmaceuticals·         Preferably, experience of both device and drug trials·         Preferably, experience of using electronic data capture in clinical trials Availability and willingness to travel to client sites. Consulting experience a bonus. Education Bachelor degree in life sciences, medical science, medical statistics, or business administration Preferably, MBA or higher university degree in life sciences, medical science, or medical statistics Preferably PMP Certification Reports to·         Director of Professional Services Responsibilities·         Project Management of client projects·         Advice and consultancy to clients on use and design of electronic CRFs and other software solutions·         Advice and consultancy to clients on clinical trial management·         Development of client specifications for electronic CRFs and other software solutions This position is located in Boston, MA.  Travel is estimated at 25 to 50% based on customer need.

Job Title: Engineer, Clinical/Project Manager Company: UMass Memorial Medical Center Location: Worcester, MA Description: Job Details: Position Summary: -Performs a variety of duties involving: -The resolution of department issues, -Preventative maintenance, repair, as well as documentation, -Special projects and assignments related to departmental efficiencies and cost saving initiatives, -In-service training to clinical and non-clinical staff, -Design and modification of medical equipment hardware/software, -Equipment technical evaluations, -Standardization and obsolescence planning, -Equipment purchase, -Installation coordination, -Regulatory agency compliance, -And disposal of retired medical equipment and related duties. Position Qualifications: -Bachelor's degree in Electrical or Biomedical Engineering. -Five to eight years of relevant experience working in progressive Clinical Engineering operations required. -Must have an understanding of methods, materials, tools, equipment and technical service procedures, for all devices managed by the Clinical Engineering Department. -Experience in computer hardware and software, and three to five years, (three years minimally in health care environment). -Moderate programming skills and knowledge of VB, VBA, XML, Access, SQL, and database architecture/security/interface protocols recommended. -Well developed interpersonal skills to successfully represent the interests of the department at all levels within the organization and affiliates to gain confidence and cooperation of others. -Advanced problem solving and analytical skills necessary to assess complex issues and evaluate data in support of process redesign. -Proven project management skills are required. -Supervisory experience with technical staff, preferred. -Clinical Engineering certification desirable. -Exprience in medical engineering in a hospital, industry or academic or equivalent setting. Click Here to Apply Online

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: Manager, Clinical Project Management Company: MED Institute Location: West Lafayette, IN Description: Manager, Clinical Project Management This management-level position is responsible for working closely with the Director of Clinical Operations and other project and process management to coordinate the activities of the Clinical Project Management team in order to meet global clinical study objectives on behalf of the Cook organization. Responsibilities: · Provide leadership to a team of clinical project managers, including personal development, performance reviews, resource management and training; · Work closely with management to determine priorities and ensure the timely initiation of clinical studies, support the clinical process as needed in order to meet study and Cook Group objectives; · Coordinate the efforts of the clinical project managers for study-related data received into the company, including medical review of protocol submissions, data collection forms, informed consent documents, analyses, adverse event review and reporting to sponsor and medical writing; · Real time accessibility to the clinical project managers and other team members to ensure timely resolution of issues; · Accountability to MED executive management and sponsors for overall clinical deliverables and timelines; · Responsible for recruitment and retention of qualified clinical managers; · Liaise with external vendors as needed to supplement internal clinical resources; · Short and long-term strategic planning; and · Establish trusted relationships with physicians, their research staff and study sponsors through communication and a commitment to exceeding expectations. Essential Qualifications: · Masters in Health, Life Sciences or Biomedical Engineering required; PhD preferred. · Prior experience (minimum 5 years) in the conduct of global clinical studies, preferably in the medical device industry; · Working knowledge of FDA and other regulatory requirements that may impact clinical studies; · Conscientious, influential person with an outstanding work ethic and strong personal discipline; · Willingness and capability to handle multiple projects and responsibilities; · Sufficiently assertive to deal with confrontational situations; · Excellent organizational, leadership and problem-solving skills; · Excellent written and verbal communication skills; · Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues; and · Willing and able to travel 25-50% of the time. Company InformationMED Institute, Inc. was incorporated in 1983 to identify and develop new medical product concepts. From conception to product marketing, MED Institute provides a continuum of services to support the medical product manufacturer. The staff includes over 100 engineers, scientists, clinical specialists, physicians, nurses, and technical personnel. Members of MED Institute's team maintain several certifications, including Regulatory Affairs Certified (RAC) from the Regulatory Affairs Professionals Society (RAPS), Certified Clinical Research Associate (CCRA), Association of Clinical Research Professionals (ACRP), and Lead Auditors. We provide a dynamic and challenging work environment found to be especially rewarding to those with initiative. Due to an increasing number of requests for our expertise, we are seeking additional leadership. BenefitsBenefits include 401k and profit sharing plans as well as health , dental, life insurance, optical insurance, eight paid holidays per year, and vacation. MED Institute is an Equal Opportunity Employer (EOE).al, life insurance,

Job Title: Clinical Project Manager - Arden Hills Company: Boston Scientific Location: Maple Grove, MN Description: Company: Boston ScientificJob Title: Clinical Project Manager - Arden HillsLocation: Maple Grove,MNStatus: Full Time,EmployeeJob Category: Clinical Project Manager - Arden HillsDescription Clinical Project Manager Delivering on the promise of medical innovation begins at Boston Scientific! By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce. General Summary: Provides project management and leadership to plan, prepare and execute one (or more) high quality clinical project(s). Leads the clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline. Internally interfaces with data management, biostatistics, clinical research associates, trial coordinators, field clinical monitors, business alliance leads, medical directors, functional management, and acts as BSC liaison with site investigators and clinical site staff. Duties and Responsibilities: · Responsible and accountable for one or more clinical trial(s). · Responsible for ensuring the trial is "audit ready" at all times (project team training records, central files, system validation, etc.). · Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables. · Responsible for effective communication within the Clinical Project Team and with functional management. · Provides regularly updates regarding the status and progress of the trials (Therapeutic Lead, Business Alliance, etc.) · Manages the project(s) within the approved budgets and timelines. · Responsible for writing of clinical project deliverables such as protocol, final study report, study manuals, study tools, operational plans, etc. within the CPP framework. · Prepares investigational site lists and participates in reviewing and approving investigational sites. · Directs forecasting of devices necessary for project in collaboration with supply-chain; reviews and approves various support system specifications (e.g. IVRS, etc.). · Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team. · Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed. · Responsible for the identification of project risks and the development and implementation of the mitigations for these risks. · Prepares and presents the status of the clinical project(s) to the Clinical Management Board. · Represents Clinical on PDP core teams (with or without a clinical trial). · Provides updates to the PDP core teams about the product risk documents (CRBA, FMEA, etc.). · Responsible for corrective action plans at individual sites and across trial. May participate in internal/external trial-related audits. · Demonstrates thorough knowledge of and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies. Minimum Education & Experience: Bachelor's-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. 5-7 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 1-3 years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Working Conditions: General office environment, approximately 25% travel to research laboratory or hospital settings, meetings and other BSC facilities.Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.Please visit us online at www.bostonscientific.comfor more information.