Clinical Project Manager
Our client is a biotechnology company. They have asked us to assist them in a search for a Clinical Project Manager.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Facilitates cross-functional study teams in the timely delivery of clinical trials.
- Assists in the development of study design, documents, and plans.
- Tracks and helps drive development to completion within timelines.
- Supports development of comprehensive study budgets in partnership with CTM and other functions as relevant.
- Helps the team manage costs to established budgets.
- Develops study-related forecasts (e.g., site activation, enrollment, drug supply, spend, team performance, etc.).
- Establishes and maintains comprehensive timelines for each study, and uses these timelines to help drive study team activities.
- Collaborates with the Program Manager to ensure alignment of clinical project timelines.
- Initiates and/or facilitates RFI, RFP, and other vendor management and oversight activities.
- Contributes to the development and implementation of various cross-functional study plans and materials.
- Facilitates ongoing risk management activities including identification and tracking of risks/issues.
- Facilitates cross-functional team meetings and vendor meetings.
- Establishes, reviews, and tracks Key Performance Indicators /metrics for performance and quality.
- Negotiates and manages competing priorities across functions to ensure on time, within spec delivery.
- Prepares reports (financial, project, etc.) for management on project status.
- Ensures study activities are conducted in compliance with applicable regulations.
- Learns and increases understanding, and awareness related to drug development, clinical trials, related regulations, study indications, scientific understanding, and trial related technology solutions.
- Contributes to the development and maintenance of a positive team-focused company culture.
- A Bachelor's degree or equivalent is required, preferably in a health, science, finance, or business-related field.
- Requires a minimum of 6+ years of prior work experience with a minimum of 2+ years of experience as a project coordinator or project manager.
- Must have clinical trial experience.
- Requires project management training and knowledge of project management methodologies and tools.
- Vendor contracting and management experience is required.
- Must have knowledge and understanding of research regulatory guidelines and policies, i.e., GCP/ICH, the Code of Federal Regulations as well as other global regulations.
- Requires highly effective written/verbal communication skills.
- Proficiency with MS Word, Excel, Outlook, PowerPoint, SharePoint, OneNote is required.
- Requires experience developing comprehensive study/project timelines.
- Requires the ability to travel globally up to 30% of the time.
- Must have demonstrated strategic and tactical abilities.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.