Senior Clinical Project Manager

Company: Terumo Medical Corporation
Location: Somerset
Posted on: February 22, 2021

Job Description:

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. Job Summary: The Senior Clinical Project Manager is key to the success of the overall conduct of a clinical trial from planning, implementation, final report, to audit and BIMO investigations. This position is responsible for the operational planning for all phases of the study, including contributing to the clinical trial strategy, formulating timelines, forecasting and managing the overall study budget, developing risk management / contingency plans for minimizing impact on project objectives, site selection and management, monitoring, coordination of clinical data management and data analysis functions, CRO and vendor management. The Senior Clinical Project Manager directs, drives and facilitates work across cross-functional teams to coordinate study related operational activities and assure timely attainment of trial milestones, within budget, and deliver quality data. This position acts as the key operational interface between the study team, cross-functional teams, vendors, and study physicians. As a Senior Clinical Project Manager, will act as a mentor to junior associates leveraging knowledge and experiences to ensure best practices are implemented and followed to facilitate data quality and integrity. 1.In collaboration with the Clinical Program Manager, responsible to develop project related deliverables including the project management plan, overall clinical budget, study timeline, risk management / contingency plan, monitoring plan, communication plan, etc. 2.Accountable for the development of study related documents, including protocol, informed consent, IB, regulatory binder, training materials, etc and provides input to case report forms. 3.Accountable for Site Activation activities and manage overall study budget, track and administer payments, and provide financial updates. 4.Responsible for the proactive management and conduct of clinical trials. Provide centralized site support, communication and coordination to assure timely completion of start-up, enrollment and all other study activities. 5.Accountable for the reviews and approves trip reports, site enrollment progress and monitors the study for protocol, Federal, and local compliances. Work with appropriate groups to develop practicable solutions to problems and or initiate corrective action plans. 6.Accountable for Vendor Selection process, including RFP to contract and change order process for CROs and other external service providers (ESP). Provide day to day management of ESPs ensuring quality deliverables and adherence to the scope of work. 7.Manage clinical supply shipments and inventory. 8.Ensure compliance with Terumo policy, procedures and SOPs, GCP, and local, regional and federal regulations. 9.Provide periodic updates, reports, etc as requested. Manages on - going communication of operation issues and provides progress reports to the study team. 10. Provide direction, subject matter expertise, training materials, and mentoring to the Clinical Research team to support corporate and departmental objectives and the building of high performing teams. 11. Assist Clinical Program Manager in the development of post approval strategies, post-clinical activities, and/or market launch of products. 12. Assist Clinical Program Manager provide clinical and technical expertise as key stakeholder for applicable cross functional Product Development Plan teams. 13. Regularly interact with senior management and prepare periodic reports as required for management review. 14. Responsible for Database freeze, Database lock, annual progress reports, and final clinical study reports. 15.Responsible for Site Management and Monitoring as required. 16. Perform other clinical duties when requested. Knowledge Skills and Abilities

• --In-depth knowledgeable in all facets of clinical operations including ICH / GCP, 21CFR 50/54/56/812/814 for the conduct of clinical research studies.
• For pre-clinical and clinical activities, able to effectively manage CRO's, external vendors, and consultants.
• Working knowledge of OUS regulatory requirement (eg EU, LATAM, AsiaPac).
• Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget.
• Effective analytical and problem-solving skills.
• Strong project management skills with proven track record or prior experience on IDE and/or IND trials.
• Ability to work in a highly matrixed team environment.
• Ability to adapt to changing priorities.
• Demonstrated successful site management and monitoring.
• Proficiency with Microsoft Suite (eg Outlook, Project, Visio, Excel, Word etc) and various data management systems / EDC systems.
• Ability to travel consistent with project needs.
• BS / BA or equivalent in a health science or related field; or equivalent combination of education, training and experience.
• 10 years' experience in the medical device clinical research industry, required; pharmaceutical or biotech industry could be considered.
• 5 years clinical project management experience across all phases of clinical project / various projects (eg start up, enrollment, follow-up, close out, and BIMO investigation) strongly preferred.
• 5 years direct site management and monitoring medical device studies strongly preferred.
• Must have experience with site and sponsor level FDA BIMO investigation(s). It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Keywords: Terumo Medical Corporation, Fall River , Senior Clinical Project Manager, Executive , Somerset, Massachusetts