Senior Project Manager (Oncology Studies) HYBRID

Working under the direction of the Senior Director, Clinical Research, the Senior Project Manager (SPM) will be responsible for the overall management of all projects including liaising between the funder and the project team for oncology clinical trials managed by the organization. The Senior Project Manager coordinates the efforts of all project teams to ensure that all aspects of all projects as defined in the contract are occurring on schedule and within budget.

Job Responsibilities

• Assists the Sr. Director in all aspects of clinical trial management
• Reviews contract, protocol, budget and Case Report Forms (CRF's) in the development of the scope of the project
• Coordinates and oversees the development of project teams including members of Medical, Data Management, Regulatory, Monitoring, and Clinical Supplies departments as needed
• Oversees the development and implementation of the project plan
• Assures that all project tasks are performed per SOPs and integrated project-specific SOPs per the clinical trial sponsor, and includes the development, review and implementation of Project Specific Plans (PSPs).
• Provides overall direction for study issue resolution
• Communicates with management and fiscal personnel to ensure ongoing budget compliance through project completion
• Ensures that the study is in compliance with federal requirements, that data has been accurately reported and that all queries have been timely resolved
• Ensures that the project team communicates with funders, monitors, CRAs and sites to confirm that all protocol amendments, revisions to the Investigator’s Brochure and /or significant new adverse effects or risks with respect to study drugs are distributed to all participating sites
• Provides mentoring and training to junior staff including PMs, Associate PMs and CRAs
• Maintains a positive interaction with funders’ representatives
• Attends relevant meetings for sponsor-related activities, cooperative groups and the organization’s staff meetings
• Provides appropriate status reports to clinical trial sponsor, Sr. Director, Clinical Team Manager, and Vice President and communicate any problems at the site, especially those involving patient safety issues
• Provides information to the Sr. Director and Vice President for proposals for new contract bids, including projected resource allocation for project management time, number of monitors, and monitoring time

Experience

• A minimum of ten (10) years strong health care related background with prior oncology clinical trial management and/or data management services experience is required.
• Experience in pharmaceutical industry, contract research organization, site network and multisite trial management experience is required.
• Computer literate in Microsoft Office and other required and related systems.  Mastery of Excel is required

Education

• Bachelor's degree from an accredited college or university is required.  An appropriate Master’s Degree and SOCRA certification is preferred