Director/Associate Director Clinical Operations
Director, Clinical Operations 1374507
Location: Needham, MA (Onsite)
Therapeutic Areas: Immunology
Working closely with an experienced VP Clinical Operations Leader to drive early phase programs forward.
- Provide operational and implementation expertise to Clinical Operations trial team(s) to enable timely progression of clinical development programs
- Function as Clinical Operations lead for clinical development program(s) ensuring successful planning, implementation and conduct of all assigned clinical trials
- Work with the cross-functional project team to identify and evaluate issues in the program and suggest and implement solutions
- Provide oversight for development of trial-specific documents (e.g., informed consent forms, study plans/guidelines, operation manuals & training materials)
- BA/BS in a scientific field of study with a minimum of 8 years of relevant experience working in in the pharmaceutical/ biotech industry, including at least 4 years of clinical trial management experience and full trial life-cycle experience (e.g., start up to closeout)
- Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning etc.
- In-depth understanding of industry standards and applicable guidelines including FDA regulations and ICH GCP guidelines
- Experience in developing Clinical Operations SOPs and trial metrics
- Proven team leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment
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