Job title: Associate Director Clinical Operations
Company: Actalent
Job description : Description:
Accountable for overall management of multiple clinical trials including:
Providing strategic direction to study teams to meet corporate study goals and timelines;
Oversight of vendor budgets and contracts, in conjunction with Development Outsourcing reporting and justification of study metrics to executive management, as requested.
Contributes expertise in all operational activities pertaining to the execution of clinical trials.
Partners with and maintains regular contact with relevant departments such as Regulatory Affairs (RA), Biostatistics and Clinical Data Management (BCDM), and others as necessary.
Participates in the selection of Contract Research Organizations (CROs) for both large budget ($20 million) and small budget ($1 million) trials.
May attend CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals.
Provides consistent, regular oversight of CRO and vendor performance.
In partnership with Clinical Operations senior management, contributes to definition, development and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices.
Contributing member of various study and program teams such as the Study Management team (SMT); provides direction to lead CTMs in creating meeting agendas and documenting outcomes and deliverables.
Contributes to the development of staffing/resourcing plans.
May act as designee for Vice President, Clinical Operations, as appropriate.
Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed.
Additional Skills & Qualifications:
Education/Experience:
BS/BA and a minimum of 11 years of related experience; or
MS/MA degree in related discipline and a minimum of 9 years of related experience; or
Equivalent combination of education and experience.
May require certification in assigned area.
Experience/The Ideal for Successful Entry into Job:
Experience in Biotech/Pharmaceutical industry preferred.
Management experience including outsourcing to Contract Research Organizations (CROs).
Experience Level: Expert Level
Location: Alameda, CA
Expected salary:
Job date: Mon, 27 May 2024 07:48:11 GMT
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