We are seeking a highly motivated and experienced Clinical Operations professional to lead the planning, execution, and oversight of clinical trials. The ideal candidate will be responsible for ensuring clinical studies are conducted in accordance with regulatory requirements, timelines, budgets, and quality standards. You will collaborate cross-functionally and lead clinical teams to drive trial success.
Key Responsibilities:
- Provide leadership and oversight for the operational management of clinical trials from study start-up through close-out.
- Serve as the primary point of contact for internal stakeholders, vendors, and investigative sites on trial management matters.
- Develop and manage study timelines, budgets, risk mitigation plans, and key operational documents (e.g., monitoring plans, site communication plans).
- Ensure compliance with protocols, GCP (Good Clinical Practice), SOPs, and applicable regulatory requirements.
- Lead site selection, initiation, monitoring, and close-out activities; review monitoring visit reports and support issue resolution.
- Oversee vendor selection and management (e.g., CROs, laboratories, imaging providers).
- Facilitate team meetings and maintain effective communication across study teams.
- Provide mentorship and guidance to Clinical Research Associates (CRAs) and other study team members.
- Participate in the development of clinical trial protocols, study manuals, informed consent forms, and other trial-related documents.
- Prepare study status reports and support regulatory submissions as needed.
- Contribute to continuous improvement initiatives within the Clinical Operations department.
Qualifications:
- Bachelor’s degree (minimum) in a life science, nursing, pharmacy, or related field. Advanced degree preferred.
- 5+ years of clinical trial management experience within the pharmaceutical, biotechnology, or CRO industry.
- Demonstrated ability to manage multiple trials across different phases (Phase I–III) preferred.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Excellent project management, organizational, and leadership skills.
- Strong interpersonal skills with the ability to work collaboratively across teams and vendors.
- High level of accountability, attention to detail, and a solution-oriented mindset.
- Ability to travel as needed (up to [insert % or "minimal travel"]).
Preferred Qualifications:
- Experience leading global trials.
- Oncology, rare disease, CNS, or other therapeutic area expertise a plus.
- Experience working in a fast-paced, dynamic environment such as a small to mid-sized biotech or CRO.
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