Our Client, a growing Pharmaceutical Company, is looking for a Clinical Project Manager.
The Clinical Project Manager will be responsible for:
- Overall responsibility for overseeing and executing on deliverables for assigned clinical trials.
- Preparing, overseeing, and reviewing documents pertaining to assigned clinical studies.
- Setting up clinical study meetings.
- Ensuring availability of resources for assigned clinical projects.
- Work with CTAs in order to help oversee and manage documents that are related to the clinical studies
The Clinical Project Manager (CPM) will be responsible for overseeing all aspects of assigned clinical trials from start up through close out according to ICH/GCP guidelines and applicable SOPs.
The CPM will work collaboratively with cross functional team members, investigators, sites, and other vendors to ensure successful delivery of high quality data that meets timelines while maintaining fiscal responsibility within budget per protocol and contractual obligations. Additional responsibilities include but are not limited to the following:
- Serve as primary point of contact for investigative sites; manage site communications (e.g., updates on progress towards enrollment goals, site issues that need resolution) throughout study conduct period
- Actively monitor patient recruitment efforts at investigative sites; escalate any barriers/issues identified during monitoring visits
- Review essential documents prior to release for distribution by site personnel
- Develop country, region, or site-specific plans in collaboration with appropriate internal stakeholders aimed at achieving target enrollment numbers
- Attend project team meetings; prepare meeting minutes as needed
- Assist with development and maintenance of project tools/templates (e.g., tracking tools, timelines) used by project teams working on similar types of studies
The Successful Applicant Should Possess The Following Qualifications:
- A minimum bachelor’s degree is required; advanced degree preferred
- 4 years pharmaceutical industry experience OR equivalent combination of education & experience required - 2 years in a Project Manager capacity.
- Strong understanding GCP Guidelines required
- Proven track record in building collaborative relationships with customers & co-workers across functions is essential
- Highly organized self-starter who takes initiative yet can also function well within a team environment under tight deadlines
- Excellent verbal & written communication skills as well as computer literacy are critical requirements for this position along with excellent time management & prioritization skills.