Senior Clinical Trial Manager

Responsibilities:
- Independently lead planning, execution, and delivery of clinical studies per GCP/ICH, SOPs, and regulatory requirements.
- Drive study timelines, enrollment execution, and operational milestones; maintain visibility into critical paths, dependencies, and timelines.
- Anticipate operational risks and implement mitigation strategies to prevent delays or quality issues.
- Lead or significantly contribute to study start-up and site activation (site feasibility, vendor coordination, regulatory package readiness, site timelines).
- Support investigator selection, site qualification, and initiation activities.
- Build and maintain relationships with investigators and study physicians; support enrollment strategy and site performance.
- Serve as primary operational contact for CROs and vendors; ensure performance, timelines, and quality; lead vendor governance and issue resolution.
- Oversee eTMF completeness, quality, and inspection readiness; ensure timely filing and quality control in Veeva eTMF and other clinical systems; support audit/inspection readiness.
- Collaborate with Clinical Development, Program Management, Biometrics, Regulatory, QA, and Finance; resolve operational challenges.
- Serve in an unblinded operational role when required, maintaining confidentiality and protocol compliance.
- Forecast and monitor study budgets with Finance and Clinical leadership; identify and address risks to timelines, resources, or costs.
- Travel to investigator sites, meetings, and vendors as required.
- Identify and implement process improvements to enhance execution and efficiency.

Qualifications:
- Bachelor’s degree in life sciences or related field (advanced degree a plus).
- 7–10 years clinical research experience in biotech/pharma, including managing clinical trials.
- Demonstrated experience managing timelines, vendors, and operational risks.
- Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
- Experience with CTMS, EDC, and eTMF; Veeva eTMF or comparable systems.
- Experience supporting study start-up and site activation.
- Ability to operate independently, prioritize, and drive execution in a fast-paced, changing environment.
- Strong organizational, communication, and problem-solving skills.

Preferred:
- Experience in ophthalmology, advanced therapies, or small to mid-size biotech.
- Experience in an unblinded study environment.
- Experience engaging investigators and study physicians directly.

Working Conditions:
- Office setting when not traveling; domestic and international travel may be required.