What are the responsibilities and job description for the Senior Manager/Associate Director, Clinical Operations (Waltham, MA) position at CEDENT?
Responsibilities:
- Support the day-to-day internal and external clinical operations activities to support the execution of the Phase 2 registrational study in AML, ALL and MDS.
- Manage external resources including consultants, CROs, central labs and other vendors to ensure study deliverables are met.
- Lead the RFP and vendor evaluation process to identify and select new vendors.
- Serve as the main point of contact with clinical sites to triage questions.
- Contribute to the development of study documents including protocol amendments, study plans, ICFs, IBs, CRFs, etc.
- Participate in data review with other core functions such as medical and data management.
- Work with the CRO and internal stakeholders to respond to IRB and EC questions.
- Work with the internal supply chain group to ensure delivery of leukopaks and drug product to and from the sites to Client’s internal GMP facility and forecast future drug needs.
- Oversee site feasibility activities to identify new US and ex-US sites.
- Ensure studies are executed in compliance with internal SOPs and following ICH, EMA, ICH-GCP and other relevant guidances.
- Build and maintain effective relationships with clinical sites, including triaging day to day issues, presenting at SIVs, etc.
- Bachelor’s degree required
- 8 -10 years of experience managing oncology clinical studies on the sponsor side; prior experience with hematologic cancers required
- Experience in cell therapy studies highly preferred
- Excellent communication skills and ability to work in a flexible, matrix environment
- Knowledge of drug discovery and development program management from Phase 1 – registrational studies
- Advanced working knowledge of all relevant guidelines, including ICH, GCP, and other relevant FDA guidances
- Working knowledge of EMA regulations
- Excellent oral and written business communication skills
- Experience managing direct reports
- Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders
