Oversee the planning, execution, and delivery of clinical trial operations, potentially across multiple studies
Provide strong matrix management and guidance to ensure teams achieve key milestones on time and with quality
Manage study operations within budget and established timelines, ensuring compliance with GCP, SOPs, and regulatory standards
Champion collaboration and accountability across all aspects of study delivery
Lead trial execution strategy and operational oversight by developing and driving the study operational plan, execution approach, and vendor-governance cadence
Oversee quality control by developing, implementing, and training on SOPs
Responsible for developing and managing clinical trial budgets, including site agreements, forecasting, accruals, and FTE allocations
Build and maintain strong relationships with investigators and site staff
Provide oversight of CROs and vendors, including selection, contracting, onboarding, and performance management
Partner with cross-functional teams to ensure efficient trial operations
Directly manage and develop team members (as applicable) by hiring/onboarding, setting clear goals, coaching, and providing timely feedback.

Requirements

Hold a bachelor’s degree in a scientific/medical field (or equivalent experience)
At least 10-12 years of Clinical Operations experience within the biopharma industry
Proven success leading cross-functional teams to deliver clinical trials from start-up through close-out, including financial oversight, data review, database lock, and reporting
Strong vendor management expertise and experience with submission-ready eTMF, quality assurance, SOP development, and CAPA management
In-depth knowledge of clinical trial design, protocol development, GCP, ICH E6 (R3), and GDPR, with preferred experience in rare/orphan disease studies
Recognized for leadership, with excellent communication, organizational, and multitasking skills; proficient in tools such as Smartsheet is a plus
Travel is required on a periodic basis to carry out responsibilities.

Benefits

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical trial operationsbudget managementGCPSOP developmentCAPA managementclinical trial designprotocol developmentdata reviewvendor managementeTMF

Soft Skills

leadershipcommunicationorganizational skillsmultitaskingcollaborationaccountabilitycoachinggoal settingfeedback provisionmatrix management