Job Description: Clinical Project ManagerJob title Clinical Project Manager I

Reports to Vice President, Clinical Operations

Job PurposeLead GRN project teams to include project planning, on-time and completion of project tasks by all network sites and GRN functional groups, adherence to budget, client interfacing, and invoicing.

Duties and Responsibilities1. Develops project plans (including risk management plans), timelines,

milestones, communication plans, resource needs, and success criteria in collaboration with GRN staff; implements action plans to meet deadlines

2. Manages GRN staff on a matrix basis for assigned projects3. Develops operational plan for GRN partner sites to implement in order

to meet recruitment goals4. Ensures readiness of IT tools/applications critical to the success of a

project5. Ensures study startup and subject recruitment occur within timelines6. Negotiate contractual scope changes with GRN clients when

appropriate, in collaboration with GRN management7. Track and analyze time budgeted vs. time spent by GRN team

members, and take appropriate steps to proactively mitigate potential overages

8. Routinely analyze prescreening, screening, and enrollment data in order to identify and mitigate delivery threats

9. Manage delivery of external vendors if applicable to a project10. Communicates progress to clients, GRN leadership, and GRN partner

personnel11. Handles other duties as assigned.

Training• Training will be provided on the following:

– GRN data elements and systems– Assigned study/project protocols– Workflow(s) required for assigned projects– GRN HIPAA/Privacy & Security Training

Qualifications

Minimum Qualifications: Bachelor's degree (preferably in a field related to healthcare, clinical research,

or business administration) Understanding of clinical research fundamentals Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH

GCP guidelines, requiredExperience:

Job Description: Clinical Project Manager Two or more years cross-functional project management experience at a

clinical research site, CRO, or pharma/biotech/device company including accountability for study enrollment

Required Competencies/Knowledge, Skills and Abilities: Functional knowledge of clinical research workflow and regulations Ability to quickly learn new software applications Strong written and verbal communication and presentation skills Strong organizational skills, including ability to manage multiple deliverables

across multiple projects Excellent office productivity skills, especially with MS Word and Excel, as well

as strong familiarity with clinical trials management software Adaptability and flexibility Ability to complete tasks independently, accurately, and within compressed

timelines

Working conditionsDay shift with standard working hours (8AM – 5 PM); Office environment with regular computer usage. Estimated 15% travel required.Direct reportsThis position is not intended to have direct reports but will require supervision of project team members within a “matrix” organizational structure.

Approved by:

Date approved:Reviewed: