Senior Manager, Site Management – Oversight Lead

📋 Description

• Responsible for the strategic and operational management of investigational site oversight and monitoring activities across designated clinical studies or programs.

• This position ensures that clinical trials are conducted with exceptional quality, regulatory compliance, and operational efficiency, in alignment with global clinical development strategies.

• Working within a matrix environment, this role collaborates with internal stakeholders and external service providers to develop and execute study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks.

• The position is crucial for maintaining sponsor oversight, validating the effectiveness of study and site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks.

• Establish and nurture strong, trusted relationships with investigators and site staff – Representing CSL.

• Act as the primary point of contact for the sponsor for assigned studies.

• Comprehend site capabilities, constraints, and strategic priorities to enhance site engagement and foster long-term collaboration.

• This role will involve travel to Investigator Meetings, Investigator sites, and CROs, with anticipated travel exceeding 50%.

• Gather feedback from sites and advocate for internal process simplification and burden reduction.

• Identify opportunities for enhancing study materials and operational processes.

• Represent the “voice of the site” in cross-functional discussions and initiatives.

• Provide local site intelligence to feasibility teams.

• Support site development.

⛳️ Requirements

• Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, or medical laboratory technology.

• Over 10 years of clinical research experience within the pharmaceutical industry.

• Experience in leading and managing a team, as well as site management, monitoring, and overseeing large and/or complex global clinical trials.

• Strong understanding and experience in the drug development process, particularly each step within the clinical trial process.

• Proven experience in budget forecasting and management.

• Extensive understanding of ICH guidelines/GCP and their applicability to all stages of the clinical development process.

• Experience and ability to mentor and coach others through peer-to-peer interactions, helping to develop reporting personnel in complex clinical project management skills.

• Proficient in independently navigating new or novel indications, study/program approaches, and unique challenges.

• Excellent comprehension of all tasks involved in a clinical development program, from protocol development through to the finalization of a clinical study report.

🏝️ Benefits

• For more information on CSL benefits, visit How CSL Supports Your Well-being | CSL.