Responsible for the planning, implementation and conduct of clinical trials in a fast paced Biotechnology environment. Provide leadership with regards to the overall strategic planning and successful implementation of multiple clinical development programs. Accountable for the internal and external work product for clinical operations, data management, biostatistics, regulatory and pharmacovigilance to ensure program milestones are met.
Responsible for clinical operations functional activities related to the execution of clinical studies based upon department and corporate goals and objectives as well as the management of study timelines and budgets. Oversee the tactical implementation of the clinical development plan for all assigned clinical programs by managing the site contracts, budget, timelines, CRO resources, enrollment, and site activities. Develop and execute a strategy to ensure that all assigned clinical study operations activities are conducted efficiently, meet enrollment goals, and are in compliance with all applicable regulations and company policies and procedures. Oversee the data collection activities for all assigned clinical programs. Provide input on CRF design and ensure quality data is monitored and available to support annual reports, investigator brochures, regulatory filings, and safety summaries. Participate in the evaluation, selection and management of CROs, contractors, and vendors. Manage overall clinical trial budget and timelines for all assigned clinical programs. Develop and maintain effective working relationships with internal team and external partners. Identify issues that may impact the overall project plans and initiate contingency plans, as appropriate. Provide positive, professional leadership as the Clinical Operations representative for OncoMed Pharmaceuticals.
Detailed knowledge of the drug development process, Good Clinical Practices and FDA regulatory requirements
Highly organized and able to prioritize and handle multiple tasks simultaneously
Experience with conducting early Phase oncology clinical trials
Experience with management of multiple services for multinational clinical trials
CRA site monitoring and CRO management experience
Experience with clinical database/eCRF design
Ability to independently solve problems related to CRO and site management activities
|OncoMed Pharmaceuticals, Inc.|
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