Senior Clinical Project Manager
Company: Terumo Medical Corporation
Posted on: February 22, 2021
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,
- 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
- 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
- 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
- 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
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