Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, regulations/guidelines, and applicable SOPs. They are a key or primary operational contact for the study. Responsibilities may include timely operational direction of and oversight of the performance and quality of one or more vendors and Contract Research Organization (CRO) teams. They should have the ability to proactively identify and manage risk, have critical thinking skills for the problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understanding upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
ESSENTIAL DUTIES & RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Ensure clinical studies are conducted in compliance with FDA regulations, ICH guidelines, and company SOPs and policies.
- Manage contract service providers (CSPs) and clinical sites (as appropriate) for assigned studies.
- Manage study activities, including investigator recruitment and site selection, study start-up, enrollment, data collection, drug projections, study close-out, submissions, and reports.
- CRO and vendor selection, development of RFPs, budget negotiations and management, risk mitigation, and manage timelines and performance to meet project and corporate goals.
- Manage CROs and other vendors (IxRS, laboratories, IRBs, imaging, ECG, recruitment, etc.), as applicable, to ensure proper study/project execution.
- Perform monitoring, co-monitoring, and/or oversight visits for protocol and GCP adherence, as necessary.
- Actively participate in technical and study design discussions and provide input to clinical trial outlines, protocols, clinical study reports, consent forms, case report forms, study manuals and plans, and other relevant study materials, as necessary.
- Work with Medical Directors to resolve subject eligibility and protocol deviation issues.
- Participate in data review meetings.
- Manage and resolve study issues, with effective escalation as appropriate. Develop and manage study timelines and performance in accordance with corporate, department and project goals. Identify barriers to enrollment, and develop and implement recruitment solutions.
- Lead and manage with minimal supervision. Able to work independently in a fast-paced environment.
- Coordinate and/or participate in the mentoring and training of junior and other development staff as assigned.
- Participate in and perform additional department and organization tasks and duties as assigned.
- Minimum 5 years clinical study management experience including serving as study lead; global study experience preferred
- Experience in oversight of and interactions with vendors and/or CRO study execution preferred
- Able to deal with and manage time demands, timelines and limited/incomplete information in a fast-paced environment
- Clinical trial project management skills,
- Familiar with advanced concepts of clinical research,
- Financial budgeting and forecasting skills,
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes,
- Disease / therapeutic knowledge preferred
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.