Project Manager - Clinical Research (home-based)
NOTE: This role may be based remotely anywhere in the U.S.
A Project Manager (PM) is responsible for overseeing and conducting clinical research studies and projects. The Project Manager will oversee all assigned clinical research staff to ensure that efficient and effective management of clinical study activities is being maintained. The PM may be responsible for multiple projects and must be able to work independently and in a team environment to effectively lead and drive the project deliverables. The Project Manager will serve as a primary resource and point of communication for the client and project team.
- Support Proposals & Business Development as necessary to secure new business, including but not limited to, providing review and input to Requests for Proposals (RFPs) and presenting at bid defense meetings as requested.
- Overall coordination and management of clinical trials from startup to closeout, within the contractual timelines.
- Project specific financial management, including but not limited to, contract adherence, budget management and regular budget reviews with the client.
- Provide and/or endure study-specific training for the clinical research staff.
- Generate a comprehensive and detailed study-specific Project Plan (PP) and ensure underlying functional plans are included.
- Establish and manage processes to track and analyze critical project information & metrics, including but not limited to, timeline management, project projections and forecasts, and trend and gap analyses.
- Serve as the primary liaison between the AC study or clinical team and the client.
- Escalate significant issues to the Director, Project Management or other appropriate AC Operational Leadership.
- Follow applicable Standard Operation Procedures (SOPs).
- Ensure compliance with applicable GCPs through training, processes, and early issue identification and correction.
- Collaborates with other functional areas to identify and evaluate fundamental issues on the project, interpret data, make good business decisions, and ensure the implementation of timely solutions.
- Develops and implements risk management strategies and contingency plans for clinical deliverables.
- Maintains a flexible approach to address issues innovatively and proactively.
- Leads client and cross functional meetings.
- Oversees study team member performance and assesses workload and resourcing
- Perform other duties as requested by Director, Project Management
The ideal candidate should have a Bachelor's Degree or RN with 5 or more years of industry experience, or a Master's degree with 3 or more years of industry experience, or an equivalent combination of education, training and experience. The ideal candidate has excellent organizational and time management skills and can successfully direct projects and deliverables. Must have proven leadership, written and verbal communication skills, and computer competency with Microsoft Word, Excel and Powerpoint. Advanced knowledge of, and ability to apply, all applicable regulations and guidelines including GCP. Project management certification is a plus.
Minimum Training Requirements
The list below includes the general training subjects, and not necessarily the exact name of the training course obtained:
- Applicable Standard Operating Procedures
- 21 CFR Part 11 and all applicable parts
- FDA Guidance Documents including ICH E6
- Drug and Device Development and Approval Process
Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.
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