We're looking for a Clinical Operations Lead III, working in the Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States.
Partners with Medical Research and other functions.
Develops scientifically robust, operationally feasible and clear protocol concepts and data monitoring plans.
Leverages appropriate on going data review to identify and mitigate patient, study design, data or study conduct issues.
Ensures all operational aspects support end point integrity and data validity.
The pay range we're offering is 80 to 95 per hour. This position may present an opportunity to go permanent.
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
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 preferred
Deep understanding of clinical development within one or more phases of trials (Phase I, II, III, IV)
Working understanding of cross functional drug development
Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas
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 organization.
Excellent project management skills, including risk assessment and contingency planning
Effective 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? Apply here.