Manager, Clinical Trial Operations

Smart IMS • Bridgewater, NJ

19h • Remote

About The Position

The Manager, Clinical Trial Operations supports the Clinical Operations Lead and/or Senior Clinical Trial Manager in managing and executing clinical trial activities in compliance with GCP and applicable regulations. The role oversees regional trial activities and helps coordinate cross-functional study teams to deliver work with high quality, on time, and within budget. It includes site and CRO oversight, study-document development and review, site feasibility and investigator engagement, risk-based quality management, project planning, data-review coordination, and inspection-readiness support.

This is a remote, 24-month contract role. The stated hourly range is $90.00 to $100.00, with rates dependent on skills, experience, location, and industry.

Requirements

• Minimum of 5 years of clinical trial management experience in the pharmaceutical or biotechnology industry, managing clinical-trial logistics.
• 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.
• Strong leadership skills and ability to work successfully in a matrixed team environment.
• Ability to work independently with limited oversight and proactively assist colleagues and/or the manager.
• Critical-thinking skills for problem-solving, conflict resolution, collaboration, and interpretation.
• Excellent written and oral communication, conflict-management, time-management, and organizational skills.
• Ability to exhibit the corporate competencies of Collaboration, Accountability, Passion, Respect, and Integrity, along with position-specific competencies.

Nice To Haves

• Bachelor's degree in life sciences, healthcare, or a related field is preferred.
• Experience in rare disease and/or orphan indications.
• Experience managing large and/or complex studies and project teams.

Responsibilities

• Support the Clinical Operations Lead and/or Senior Clinical Trial Manager with management and execution of clinical trial activities in compliance with GCP and relevant regulations.
• Manage and oversee regional trial activities.
• Coordinate cross-functional clinical study team activities, information-sharing, study meetings, deliverables, and risk management.
• Manage regional monitoring oversight of site-level activities for ongoing and planned trials.
• Support development of action plans addressing protocol compliance, safety, data, and administrative issues at investigator sites.
• Participate in development of clinical trial synopses, protocols, amendments, Case Report Forms, IRB/Ethics applications, and recruitment materials.
• Create, review, and approve study documents such as informed consent forms, study guidelines, operations manuals, training materials, and study plans.
• Liaise with CROs and legal teams to provide language acceptable to IRBs/ECs.
• Participate in site feasibility assessments with Clinical Development, Medical Affairs, and Clinical Operations colleagues, evaluating site capabilities, patient access, investigator experience, and therapeutic-area expertise.
• Collaborate with regional MSLs, where applicable, to support investigator engagement; may help organize investigator engagement meetings or conference events.
• Participate in Risk-Based Quality Management activities to support data integrity and patient safety.
• Implement risk-based and centralized monitoring strategies with CROs as applicable; this is not applicable to early-phase trials.
• Develop and manage detailed project and trial-related plans.
• Support planning for and potentially attend investigator meetings, kick-off meetings, monitoring training, and CRO or other vendor meetings.
• Attend site visits for CRO oversight and/or investigator engagement as needed.
• Support oversight of CRO and vendor performance through review of study metrics, milestone tracking, and quality assessments.
• Manage vendor adherence to contractual obligations, identify potential scope changes such as costs or timelines, and work with the COL/Sr. CTM on timely contractual documentation.
• Collaborate with Data Management, functional teams, vendors, and the CRO to achieve database-lock milestones.
• Work with the Clinical Scientist, Clinical Development Lead, and study team as needed to review patient profiles and data listings.
• Support inspection readiness throughout the trial, including appropriate Trial Master File filing and reconciliation at study end.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager