Clinical Trial Business Operations - Manager

Our client, a leading healthcare organization, is looking for a Clinical Trial Business Operations - Manager to start right away. This position is hybrid in Bridgewater, NJ.

Location: Bridgewater, NJ

Key Responsibilities

• Detailed management and oversight of regional/global trial activities, accountable for achieving site activations and enrollment milestones in assigned region.
• Coordinate cross-functional study clinical team activities to ensure deliverables are completed with high quality, within agreed timelines, and on budget through information-sharing, ongoing study team meetings/discussions, and effective risk management planning.
• Develop and manage detailed project and other trial-related plans and documentation, providing regular study status updates to senior management.
• Review and contribute to the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials.
• Create and/or review and approve specific study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, study plans. Liaise with CRO and legal to provide language acceptable for IRB's/EC's.
• Drive timely and efficient execution of site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues, including evaluation of site capabilities, patient population access, investigator experience, and therapeutic area expertise, to inform site selection decisions and ensure alignment with study objectives and enrollment targets.
• Collaborate with regional MSLs (if applicable) to support investigator engagement activities. May support organization of investigator engagement meetings or events at industry congresses/conferences.
• Accountable for development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites.
• Participate in risk-based quality management (RBQM) activities to ensure data integrity and patient safety.
• Implement risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs as applicable. Note: This is not applicable for early phase trials.
• Support COL with planning, and may attend and present at investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
• May attend 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 to close-out, through regular review of study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met.
• Apply critical thinking skills and trial management experience to actively engage with vendors, ensuring proactive risk management, timely and thorough issue resolution, protocol compliance, and compliance with local regulations as applicable.
• Review vendor Statements of Work/agreements and provide input from a site management/operational lead perspective.

Data Review

• Collaborate closely with Data Management and other functional areas, vendors, and the CRO to achieve database lock milestones during the project lifecycle.
• Work collaboratively with Clinical Scientist, Clinical Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.

Inspection Readiness

• Support inspection readiness preparation and maintenance throughout the life-cycle of the trial, including but not limited to ensuring Trial Master File documents are appropriately filed, and reconciled at end of the study.

Qualifications

• Minimum of 7 years of clinical trial management experience within pharmaceutical/biotechnology industry, managing the logistics of clinical trials.
• Minimum 2 years of indirect/influence management of team members, including coaching and mentoring for knowledge sharing and enhanced communication and leadership skills.
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing global, large and/or early phase complex studies and project teams is required.
• Demonstrated experience managing global CROs and other specialty vendors is preferred.
• Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
• Demonstrated strong leadership skills and the ability to work successfully in a matrixed team environment.
• Ability to work independently with minimal oversight and proactively initiates assistance before being asked.
• Possess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretation.
• Excellent written and oral communication skills, as well as conflict management, time management, and organizational skills.
• Must successfully exhibit core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position-specific competencies.
• Bachelor's degree preferred in the life sciences, healthcare, or related field.

Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.