Senior Clinical Trials Project Manager

The Senior Clinical Trials Project Manager will be the key liaison with stakeholders including funding agencies, central vendors, study staff and trial site leads. This role requires deep expertise in multicenter interventional trial management, project management tools and techniques, cross-functional leadership, milestone-driven execution, and high-level coordination across academic, clinical, and federal funding environments.

Essential Functions

• Coordinate the development of investigator-initiated and industry sponsored project documents and timelines and manage any changes, including future timeline changes that may result from changes in scope, delays in schedule or resource constraints.
• Is responsible for all regulatory maintenance for assigned clinical research and trial projects including IRB submissions, biosafety committee submissions, FDA submissions and reporting, funding agency reporting, clinicaltrials.gov record maintenance, and other related tasks on assigned projects.
• Monitors and manages sub-sites on multi-center clinical research projects including facilitating regular sub-site status meetings, overseeing sub-site data collection and quality, and collecting sub-site regulatory documentation and ensuring compliance.
• Develop and finalize complete project plans with formalized project milestones and deliverables.
• Facilitate and maintain records of all internal and external communication relevant to assigned clinical trials.
• Responsible for Project Operating Planning Manual development.
• Present and lead presentations at site initiations or trial kick off meetings.

Qualifications

Bachelor's Degree in a related field of study required. Experience in lieu of a degree is not accepted.

Clinical Research Experience 3-5 years required.

Knowledge, Skills and Abilities

• Must be able to prioritize multiple, competing tasks with excellent organizational skills.
• Strong interpersonal and leadership skills with ability to train, supervise, mentor and support team members effectively.
• Excellent judgment and ability to make independent effective decisions in appropriate situations.
• Team building and conflict management skills.
• Ability to promote collaboration and communication within and beyond the team.