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We're looking for a Clinical Operations Lead III
, working in Biotechnology/Medical Devices
industry in Cambridge, Massachusetts, United States
- Partners with Medical Research and other functions to develop
operationally feasible and clear protocol concepts and final protocols.
- Leverages phase and operational expertise to establish study level
operational strategy in alignment with the Clinical Development Plan
(CDP) and program level strategy.
- Oversees one or more
trials by establishing the operational strategy and securing excellence
in execution through the CRO partner.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- At least 10 years of clinical research study management experience of
which at least 4 years has been with a sponsor company managing
outsourced clinical trials within quality, timeline, and budget
expectations is preferred
- Prior CRO or investigator site and/or monitoring
experience is preferred
- Deep understanding of clinical development
within one or more phases of trials (Phase I, II, III, IV) and a working
understanding of cross functional drug development
- Scientific learning
agility to quickly develop a sound working knowledge of new therapeutic
- Ability to establish operational plans and support the CRO in
the execution of the plans
- Balance of scientific and
operational/project management and team leadership expertise
- Ability to build effective relationships across and up and down the
- Excellent project management skills, including risk
assessment and contingency planning
- Effective prior CRO
management skills and ability to adapt to the GCO outsourcing model
- Ability to partner with other functions and both internal and external stakeholders.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?