Senior Manager, Clinical Trial Operations

Smart IMS•Bridgewater, NJ

1d•Remote

About The Position

The Senior Manager, Clinical Trial Operations leads and coordinates clinical trial activities in compliance with Good Clinical Practice (GCP) and applicable regulatory guidelines. The role may serve as Clinical Operations Leader (COL), accountable for trial performance, and oversees regional or global trial activities, site activation, and enrollment milestones. It coordinates cross-functional study teams to deliver high-quality work within agreed timelines and budgets, with ongoing communication and effective risk management. The role develops and manages project plans and trial documentation, provides study updates to senior management, and reviews or contributes to trial synopses, protocols, amendments, Case Report Forms, ethics applications, recruitment materials, and other study documents. It supports site feasibility and selection, investigator engagement, protocol compliance, risk-based quality management, and monitoring strategies. The position also supports investigator and vendor meetings and may attend site visits. The Senior Manager is responsible for end-to-end CRO and vendor management, including monitoring metrics, milestones, quality, risks, issue resolution, and contractual deliverables. The role collaborates with Data Management and other teams to achieve database-lock milestones and supports inspection readiness throughout the trial, including Trial Master File filing and reconciliation.

Requirements

At least 7 years of clinical trial management experience in the pharmaceutical or biotechnology industry, managing clinical-trial logistics.
At least 2 years of indirect or influence-based team management, including coaching and mentoring.
Experience managing global, large, and/or complex early-phase studies and project teams.
Demonstrated experience managing global CROs and other specialty vendors.
Thorough understanding of drug development and clinical-trial execution, including ICH/GCP requirements and local regulations.
Demonstrated leadership and ability to work successfully in a matrixed team environment.
Ability to work independently with minimal oversight and proactively assist colleagues or a 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 preferred in life sciences, healthcare, or a related field.
Experience in rare disease and/or orphan indications.

Responsibilities

Lead and coordinate clinical trial activities in compliance with GCP and relevant regulatory guidelines.
Potentially act as Clinical Operations Leader (COL), accountable for trial performance.
Manage and oversee regional or global trial activities and achieve site activation and enrollment milestones in the assigned region.
Coordinate cross-functional study team activities to deliver high-quality work within agreed timelines and budget, sharing information and managing risks.
Develop and manage detailed project and trial-related plans and documentation, and provide regular study status updates to senior management.
Review and contribute to clinical trial synopses, protocols, amendments, Case Report Forms, IRB/Ethics applications, and recruitment materials.
Create, review, or approve study documents, including informed consent forms, study guidelines, operations manuals, training materials, and study plans.
Coordinate with CROs and legal teams on language acceptable to IRBs/ECs.
Drive site feasibility assessments with Clinical Development, Medical Affairs, and Clinical Operations colleagues, evaluating site capabilities, patient access, investigator experience, and therapeutic-area expertise to inform site selection.
Collaborate with regional MSLs, when applicable, on investigator engagement; potentially support investigator engagement events at congresses or conferences.
Develop action plans to address site protocol-compliance, safety, data, and administrative issues.
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; these strategies are not applicable to early-phase trials.
Support the COL with planning and potentially attend or present at investigator meetings, kick-off meetings, monitoring training, and CRO or other vendor meetings.
Potentially attend site visits for CRO oversight or investigator engagement.
Manage CROs and other vendors from study planning through close-out, reviewing study metrics, milestones, and quality assessments to ensure contractual deliverables are met.
Engage vendors to support proactive risk management, timely issue resolution, protocol compliance, and compliance with local regulations.
Review vendor Statements of Work and agreements and provide site-management or operational-lead input.
Collaborate with Data Management, functional teams, vendors, and the CRO to achieve database-lock milestones.
Potentially work with the Clinical Scientist, Clinical Development Lead, and study team to review patient profiles and data listings.
Support inspection readiness throughout the trial lifecycle, including appropriate Trial Master File filing and reconciliation at study end.