Lead one or more Therapeutic Areas (TA) working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality.
Responsible for operational oversight of the site, site health and monitoring activities.
Support QA audit and inspection planning, and implementation of CAPAs as needed.
Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs.
Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
Support sites in understanding study expectations, timelines, and required deliverables.
Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs.
Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs.
Build and maintain strong, trusted relationships with investigators and site staff – Face of CSL.
Serve as the sponsor primary point of contacted for assigned studies.
Collect feedback from sites and advocate for process simplification and burden reduction internally.

Requirements

At minimum, bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
A minimum of 12 years’ relevant clinical research (or related) experience within the pharmaceutical industry.
Previous experience in leading and managing a team of professional staff.
A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
Experience in site management and monitoring and overseeing large and/or complex global clinical trials.
Robust budget forecasting and management experience.
Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
Demonstrated ability to lead teams and work in a fast-paced team environment.
Demonstrated ability to oversee vendors and CROs.
Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment.
Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities.
Ability to evaluate, judge and make decisions regarding staff.
Ability to teach/coaching and setting an example of ‘best practice’.

Benefits

Competitive salary
Health insurance
Retirement plans
Flexible work arrangements
Professional development
Incentive compensation
Equity

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchsite managementmonitoringbudget forecastingdrug development processclinical trial processGCPICH guidelinesCAPA implementationdata quality

Soft Skills

leadershipteam managementcommunicationrelationship buildingconflict resolutionmentoringcoachingproblem-solvingdecision-makinginterpersonal skills