Sr. Project Manager

Job Title:

Senior Project Manager, Clinical Research (Oncology)

Job Description

The Senior Project Manager oversees the full lifecycle of oncology clinical trial projects, serving as the primary liaison between funders and internal project teams. This role manages multiple trials to ensure all contract deliverables are completed on time, within budget, and in compliance with standard operating procedures and Good Clinical Practice. The position plays a key role in coordinating cross-functional teams, supporting business development activities, and mentoring junior project management and clinical research staff.

Responsibilities

+ Manage the overall execution of oncology clinical trial projects, ensuring all activities align with contract requirements, timelines, and budget constraints.

+ Serve as the main point of contact between the funder and internal project teams, facilitating clear communication, issue resolution, and timely status updates.

+ Assist the Senior Director of Clinical Research in clinical trial management activities, including planning, oversight, and strategic decision-making.

+ Review contracts, study protocols, budgets, and case report forms (CRFs) to confirm feasibility, accuracy, and alignment with project objectives.

+ Coordinate and oversee the work of cross-functional project teams, including Data Management, Regulatory, Monitoring, and Clinical Supplies, to ensure cohesive and efficient trial operations.

+ Ensure all project tasks are performed in accordance with established standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.

+ Provide mentoring, coaching, and training to junior staff, including Project Managers, Associate Project Managers, and Clinical Research Associates (CRAs), to support their professional development and performance.

+ Contribute to proposals for new contract bids by providing detailed input on resource allocation, including project management time, number of monitors, and monitoring time required.

+ Support vendor management activities, including selection, oversight, and performance evaluation of external partners involved in clinical trial execution.

+ Collaborate with data management teams to support data review, data quality initiatives, and user acceptance testing (UAT) related to clinical trial systems.

+ Participate in trial registration activities and ensure that registration requirements are met in a timely and compliant manner.

+ Identify operational risks and issues within projects and work proactively with stakeholders to develop and implement mitigation strategies.

+ Monitor project progress against milestones and deliverables, prepare reports, and communicate status and performance metrics to leadership.

+ Promote continuous improvement in clinical trial processes and contribute ideas to streamline operations and enhance the efficiency of cancer clinical trials.

Essential Skills

+ At least 10 years of oncology project management experience in clinical trials.

+ Extensive experience in clinical trial management and clinical operations within oncology.

+ Hands-on experience with registration trials and trial registration processes.

+ Strong project management skills, including planning, budgeting, timeline management, and stakeholder communication.

+ Proficiency in vendor management, including oversight of external partners involved in trial execution.

+ Solid knowledge of data management processes and user acceptance testing (UAT) for clinical trial systems.

+ Thorough understanding of Good Clinical Practice (GCP) and standard operating procedures related to clinical research.

+ Background in clinical research and clinical project management in a CRO or pharmaceutical environment.

+ Ability…