Role Summary
This position leads site management and operational oversight across one or more therapeutic areas, working closely with statistical counterparts to ensure clinical trials are delivered on time and to the highest quality standards. The role is central to maintaining site compliance, supporting study execution, and fostering long-term relationships with clinical investigators and site staff.
Key Responsibilities
- Lead therapeutic area initiatives in coordination with statistical leads to meet project timelines and quality benchmarks.
- Oversee site operations, including monitoring performance, identifying risks, and ensuring adherence to protocols and regulatory standards.
- Support audit readiness, inspection planning, and implementation of corrective actions when necessary.
- Proactively identify and address challenges related to recruitment, retention, data integrity, and compliance in collaboration with CRO partners.
- Act as the primary sponsor contact for assigned studies, managing escalated site issues and facilitating resolution.
- Guide sites on study expectations, milestones, and deliverables to ensure alignment with global and local enrollment goals.
- Drive recruitment strategies and respond to enrollment barriers raised by investigators or CROs.
- Build trusted relationships with clinical sites, serving as the main point of contact and advocate for their needs.
- Collect site feedback and promote internal improvements to reduce operational burden and enhance study design.
- Contribute site insights to feasibility assessments and support site selection and development activities.
- Represent site perspectives in cross-functional discussions and champion process optimization initiatives.
Qualifications and Experience
- Bachelor’s degree in life sciences, nursing, pharmacy, or a related medical or health field.
- At least 12 years of clinical research experience within the pharmaceutical industry.
- Proven leadership experience managing professional teams and mentoring staff.
- Deep understanding of clinical trial design, execution, and the full drug development lifecycle.
- Extensive experience overseeing global or complex clinical trials and managing CRO partnerships.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements across trial phases.
- Experience in budget forecasting, vendor oversight, and operating effectively in matrixed environments.
- Demonstrated ability to resolve conflicts, coach peers, and develop team capabilities in clinical project management.
- Excellent judgment, decision-making, and communication skills, both written and verbal.
- Proficiency in clinical operations software and standard office applications.
- Ability to adapt to novel therapeutic areas and lead through ambiguity and change.
- Skilled in managing multiple projects simultaneously while maintaining scientific and ethical standards.
Work Environment
This role offers remote work flexibility due to travel requirements. Candidates should be prepared for periodic travel to support site engagement and oversight activities.
