Project Manager, Early Phase Clinical Research
- Posted: over a month ago
We are looking for an Project Manager, Early Phase Clinical Research in support our Clinical Pharmacology Center.
This role is responsible for full cycle project management - acts as the point person in charge of assigned studies. Plan, budget, monitor and report on the project status and completion. Acts as bridge between sponsor, upper management and the department heads tasked with the execution of the study. Ensures scope of the study is sound and reports regularly on the progress of the study. Focuses on tracking the study to affirm it's staying on schedule, is within budget for the purpose of ensuring revenue recognition.
What The Job Entails:
- Collaborates with Business Development Team to execute site qualification and feasibility meetings;
- Works closely with regulatory to ensure feasibility questionnaires are accurate;
- Engages with client to ensure needs are understood and met; actively works to ensure the client gains trust on the company and are confident in our ability to execute the study.
- Responsible for contributing to proposal development which includes, but is not limited to:
- Work closely with department heads to evaluate costs for labor, equipment needs, and/or any other supplies needed for the protocol/synopsis.
- Collaborates to with Business Development and department heads to write, review and finalize proposal packages for sponsor submission.
- Initiate and host all project kick-off meetings.
- Work closely with external vendors/consultants which includes but is not limited to Medical Monitors, and Medical Writers to ensure their availability and scope of work.
- Performs a risk assessment to anticipate and propose mitigation solutions for the project throughout all phases of the study.
- Create integrated project timelines.
- Serves as central point of contact with sponsors for all deliverables.
- Identifies and facilitates resolutions to vendor issues through department heads.
- Responsible to monitor the progress of each individual project deliverable against project timelines and budget, which includes but is not limited to:
- Review and identify project study trends and proactively respond to client and respective team members.
- Conduct and document weekly project-specific telephone conferences/WebEx.
- Approve project direct and pass-thru expenditures from vendors.
- Review monthly financial reports and semi-monthly labor reports to outline expenditures for each assigned project.
- Work closely with the Project Finance Department to manage changes in project scope, budget, and revenue for all assigned projects.
- Works closely with Data Management or other departments as needed to ensure a high-quality deliverable is provided to the sponsor in a timely manner.
- Responds to all sponsor post study inquiries - collaborating with department heads as needed.
- Conduct a lesson learned session at the end of each study.
- Bachelor of Science in related field + 2 year as a Project Manager in a Clinical Research environment.
- Project Management Professional (PMP) Certification required.
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