Clinical Trial Business Operations - Manager

WhiteCap Workforce Solutions; Bridgewater Township (NJ); Hybrid; USD 120,000 - 170,000; Full time

Job summary

WhiteCap Workforce Solutions is seeking a Clinical Trial Business Operations - Manager for a hybrid role in Bridgewater, NJ. The role focuses on overseeing regional trial monitoring, site feasibility, RBQM, and vendor management within a cross-functional team.

The ideal candidate will have strong leadership, communication, and ICH/GCP knowledge, with experience collaborating with CROs and investigator sites.

Qualifications

• Minimum 5 years of clinical trial management experience.
• Experience managing CROs and external vendors.
• Thorough understanding of ICH/GCP requirements and local regulations.
• Strong leadership in a matrixed study team environment.

Responsibilities

• Oversee regional monitoring of site-level activities for trials.
• Develop action plans for protocol compliance, safety, data, and admin issues.
• Create and review study documents, including CRFs, consent forms, and study plans.
• Collaborate with Clinical Development, Medical Affairs and operations on site feasibility.
• Support investigator engagement activities with regional MSLs.
• Lead RBQM activities to ensure data integrity and patient safety.
• Implement RBM and centralized monitoring with CROs.
• Manage vendor performance and contract adherence.

Skills

Leadership

Communication

Problem solving

Time management

Collaboration

Education

Bachelor's degree in life sciences or healthcare

Job description

Our client, a leading healthcare organization, is looking for a Clinical Trial Business Operations - Manager to start right away. Hybrid onsite in Bridgewater, New Jersey.

Location: Bridgewater, NJ

Responsibilities

• Manage regional monitoring oversight of site-level activities related to ongoing and planned trials as assigned.
• Support development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites.
• Participate in 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, including informed consent forms, study guidelines, operations manuals, training materials, and study plans.
• Participate in site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues.
• Collaborate with regional MSLs to support investigator engagement activities and may support the organization of investigator engagement meetings or events at industry congresses/conferences.
• 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.
• Develop and manage detailed project and other trial-related plans.
• Support the COL and/or Sr. CTM with planning of and may attend investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
• Attend site visits for CRO oversight and/or investigator engagement.
• Support the COL and/or Sr. CTM with oversight of CRO/vendor performance through regular review of study metrics, milestone tracking, and quality assessments.
• Manage vendors' adherence to contractual obligations and collaborate with COL/Sr. CTM to ensure timely completion of contractual documents.

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, ensuring Trial Master File documents are appropriately filed and reconciled at the end of the study.

Qualifications

• Minimum of 5 years of clinical trial management experience within the pharmaceutical/biotechnology industry.
• Experience in rare disease and/or orphan indications is preferred.
• Experience managing large and/or complex studies and project teams is preferred.
• Demonstrated experience managing CROs and other specialty vendors is required.
• 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 limited oversight and proactively initiate tasks.
• 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 exhibit core corporate competencies of Collaboration, Accountability, Passion, Respect, and Integrity.

Education

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.