Contact: Lauren Scutero -
teamnt@penfieldsearch.com
No 3rd party candidates
We are partnering with a leading biopharmaceutical company seeking an experienced Clinical Trial Business Operations Manager to support the management and execution of clinical trials. This role will work closely with clinical operations leadership and cross-functional teams to ensure study activities are completed efficiently, on time, and in compliance with regulatory requirements.
Key Responsibilities
- Supports the Clinical Operations Lead (COL) and/or Senior Clinical Trial Manager (Sr. CTM) with the management and execution of all clinical trial activities in compliance with Good Clinical Practice (GCP) and relevant regulatory requirements.
- Provides detailed management and oversight of regional clinical trial activities, as assigned.
- Supports the COL and/or Sr. CTM with coordination of cross-functional clinical study team activities to ensure high-quality deliverables are achieved on time and within budget through effective communication, ongoing team meetings, and risk management planning.
- Manages regional monitoring oversight of site-level activities related to ongoing and planned clinical trials, as assigned.
- Supports the development of action plans to address protocol compliance, safety, data quality, and administrative issues at investigator sites.
- Participates in 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.
- Participates in 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.
- 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.
- Develops and manages detailed project plans and other trial-related plans and documentation.
- Supports the COL and/or Sr. CTM with planning investigator meetings, kickoff meetings, monitoring training, and CRO or vendor meetings, and may attend as requested.
- May participate in site visits for CRO oversight and/or investigator engagement.
- Supports the COL and/or Sr. CTM with CRO/vendor performance oversight through regular review of study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met.
- Manages vendor adherence to contractual obligations, proactively identifies changes in scope, costs, or timelines, and collaborates with the COL/Sr. CTM to ensure timely completion of contractual documentation, including change orders.
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 5 years of clinical trial management experience within the pharmaceutical or biotechnology industry, including management of clinical trial logistics.
- Experience in rare disease and/or orphan indications is preferred.
- Experience managing large and/or complex clinical studies and project teams is preferred.
- Demonstrated experience managing 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 limited 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.