We're looking for a Country Study Manager IV, working in the Biotechnology/Medical Devices industry in South San Francisco, California, United States.
Provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with quality standards, all applicable regulations, timelines and budget commitments.
Oversees all assigned studies at regional/country level (global and local studies) in accordance with the overall project plan, manages and maintains accurate country /study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate planning system.
Highlights deviations and risks in plans to relevant parties develop and implements mitigation strategies as required.
Leads local study teams, represents country/region clinical operations at the global SMT and provides global teams with feedback from an affiliate perspective (global).
Provides study oversight, leadership and support to Contract Research Organisation (CRO) to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
We are offering Competitive Compensation and Benefits. 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
University degree or equivalent; preferably in a medical science-related field and extensive experience and expertise in clinical research/development or related industry.
Extensive experience in clinical trial project management.
Availability to travel domestically and internationally if required.
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.