Contact: Lauren Scutero -
teamnt@penfieldsearch.com
No 3rd party candidates
Position Overview
We are partnering with a leading biopharmaceutical company seeking an experienced clinical trial management professional to lead and oversee clinical trial operations. This role will work closely with cross-functional teams, CROs, and external vendors to ensure studies are executed efficiently, on time, within budget, and in compliance with regulatory requirements.
Key Responsibilities
- Leads and coordinates the management and execution of all clinical trial activities in compliance with Good Clinical Practice (GCP) and relevant regulatory guidelines. May serve as Clinical Operations Leader (COL), with accountability for overall trial performance.
- Provides detailed management and oversight of regional and global trial activities, including accountability for achieving site activation and enrollment milestones within assigned regions.
- Coordinates cross-functional clinical study team activities to ensure high-quality deliverables are completed on time and within budget through effective communication, ongoing team meetings, and risk management planning.
- Develops and manages detailed project plans and other trial-related documentation, providing regular study status updates to senior management.
- Reviews and contributes to the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics Committee applications, and recruitment materials.
- Creates, reviews, and approves study documents, including informed consent forms, study guidelines, operations manuals, training materials, and study plans. Collaborates with CROs and Legal to ensure language is acceptable to IRBs/Ethics Committees.
- Drives timely and efficient execution of site feasibility assessments in collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues. Evaluates site capabilities, patient population access, investigator experience, and therapeutic area expertise to support site selection decisions and alignment with study objectives and enrollment targets.
- Collaborates with regional Medical Science Liaisons (MSLs), when applicable, to support investigator engagement activities. May assist with organizing investigator meetings or events at industry conferences.
- Develops and implements action plans to address protocol compliance, safety, data quality, and administrative issues at investigator sites.
- Participates in Risk-Based Quality Management (RBQM) activities to ensure data integrity and patient safety.
- Implements risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs, as applicable. This responsibility does not apply to early-phase trials.
- Supports the COL with planning investigator meetings, kickoff meetings, monitoring training, and CRO or vendor meetings. May attend and present at these meetings as needed.
- May participate in site visits for CRO oversight and/or investigator engagement.
Vendor & Contract Research Organization (CRO) Management
- Responsible for end-to-end vendor management, from study planning through closeout, including regular review of study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met.
- Applies critical thinking and clinical trial management experience to actively engage with vendors, ensuring proactive risk management, timely issue resolution, protocol compliance, and adherence to applicable local regulations.
- Reviews vendor Statements of Work (SOWs) and agreements, providing input from a site management and operational leadership perspective.
Data Review
- Collaborates closely with Data Management, other functional areas, vendors, and CROs to achieve database lock milestones throughout the project lifecycle.
- May collaborate with the Clinical Scientist, Clinical Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.
Inspection Readiness
- Supports inspection readiness preparation and maintenance throughout the clinical trial lifecycle, including ensuring Trial Master File (TMF) documents are appropriately filed and reconciled at the end of the study.
Required Skills & Qualifications
- Minimum of 7 years of clinical trial management experience within the pharmaceutical or biotechnology industry, including management of clinical trial logistics.
- Minimum of 2 years of experience indirectly managing or influencing team members, including coaching and mentoring to support knowledge sharing, communication, and leadership development.
- Experience in rare disease and/or orphan indications is preferred.
- Experience managing global, large-scale, and/or complex early-phase clinical studies and project teams is required.
- Demonstrated experience managing global CROs and other specialty vendors.
- Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
- Demonstrated strong leadership skills and ability to work successfully in a matrixed team environment.
- Ability to work independently with minimal oversight, take initiative, and proactively support colleagues and management.
- Strong critical thinking skills with the ability to problem-solve, resolve conflicts, collaborate effectively, and interpret complex information.
- Excellent written and verbal communication skills, along with strong conflict management, time management, and organizational abilities.
- Demonstrated commitment to the core competencies of Collaboration, Accountability, Passion, Respect, and Integrity.
Education
- Bachelor's degree in life sciences, healthcare, or a related field preferred.