Associate Director, Clinical Trial Lead
New
B
BiogenPharmaceutical Development
Remote, USAFull-TimeManager
Salary$162,000.00-$223,000.00
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Job Details
- Experience
- 8 + years
- Required Skills
- Project Management
Requirements
- Bachelors Degree in a scientific discipline.
- 8 + years in clinical operations management, overseeing outsourced clinical trials per quality, timeline, and budget expectations, preferably with a sponsor company and a CRO.
- Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skill.
- Extensive knowledge of clinical development related to one or more trial phases (I, II, III, or IV), as well as cross-functional drug development.
- Unquestioned expertise in Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines and regulatory requirements for clinical development.
- Ability to establish operational plans and support the CRO in executing them.
- Effective CRO management skills and ability to adapt to the Global Clinical Operations (GCO) outsourcing model.
Responsibilities
- Develop and oversee implementation of the study-level operational strategy for the successful delivery of clinical studies.
- Chair the Study Management Team (SMT) to drive development of scientifically robust, operationally feasible, and clear concepts/protocols.
- Oversee delivery of studies by CROs to ensure quality execution in line with time and budget forecasts.
- Partner with the CRO SMT lead to ensure the CRO creates appropriate risk-mitigation plans and effectively identifies/resolves issues.
- Establish and drive efficient team operations by establishing an open culture defined by communication, goal setting, and oversight of strategy implementation.
- Ensure effective, consistent, efficient and compliant processes.
- Champion synergies among other studies, programs, and development units to enhance excellence in study planning and execution.
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