Clinical Project Manager
Purpose: To describe the CPI expectations for the position of Project Manager I. Description:
Reporting to the Project Leader, the Project Manager I responsibilities include but are not limited to:
- Ensure that sponsor approved study sites are compliant to training:
- Tracks all site required training, ie, EDC training certificates and ensure that relevant and required study specific training documentation is housed in the TMF
- Communicates with the responsible CRAs to obtain training documents from sites as required
- Provides project specific training as required via phone and web-based training tools, ie Web-Ex
Updates and maintains project specific tracking tools:
- May assist the Project Manager II and/or the Project Leader in essential document tracking from study site to the TMF
- Populates sponsor approved template forms to ensure that sponsor SOPs are adhered to
- Ensure CPI approved forms are utilized by the study team to enable project milestones, objectives and timelines achieved.
With oversight provided by the Project Leader and/or Project Manager II, may be wholly responsible to project manage and achieve specific milestone goals to completion May serve the role to be the central contact conduit between CPI and the sponsor May mentor the project assistant/associate within the organization. 10% travel to conduct training presentations to applicable attendees and attend Investigator Meetings
Qualifications: MS degree in life sciences with 3 years’ pharmaceutical industry experience which includes a minimum of 2 years of pharmaceutical clinical operations experience. Or BS degree in life sciences with 4 years pharmaceutical industry experience which includes a minimum of 3 years of pharmaceutical clinical operations experience. Skills:
- Ability to create training material to the external environment on GCP/ICH guidelines is preferred
- Demonstrated ability to effectively communicate to external sponsors and internal cross-functional project teams.
- Strong time management and organizational skills.
- Strong written and oral communication skills in English.
- Ability to manage and mobilize a study team that does not report directly to you.
- Proficiency with MS Office applications, and demonstrated exposure with MS Project, or other project management software.