Clinical Project Manager
The Clinical Project Manager (CMP) will be responsible for managing the operational and fiscal activities of assigned projects developing plans that follow systems and procedures to identify risks and proposing mitigating solutions to ensure compliance with the scope of the project, ensuring operating quality and efficiency while adhering to ICH-GCP, applicable regulations and standard operation procedures. Manage project team in accordance with company policies and procedures to ensure timely project deliverable within budget. Maintain and strengthen relationships with sites, vendors, opinion leaders and clinical investigators. Responsible for training internal team members
- Manage the operational and fiscal activities for multiple projects individually or in collaboration with other PMs, including but not limited to staffing, finances, and milestones as defined in the scope of work of the project.
- Primary point of contact for internal and external clients.
- Team lead for sponsor meetings as needed ensuring agendas and minutes reflect discussions and decisions and overseeing the completion of action items as needed.
- Meet with department team lead to assess plans, processes and/or system requirements are in place to accomplish deliverable per scope of work and timelines.
- Analyze and document project progress and issues and develops solutions to enhance efficiencies and mitigate risks to the project and escalate to client, team leads or management as applicable.
- Ensure lessons learned are considered, shared and improvements included in processes, as applicable.
- Develop, manage and ensure execution of project plans as applicable per scope of project
- Oversight of project team in accordance with company and sponsor policies, procedures and relevant SOPs.
- Assist project team in resolving complex GCP, protocol and/or SOP issues.
- Review and approve, travel and expenses for the project team following project budget and company policy
- Support sales team and Senior Management with the development of new business proposal, requests for information and bid defense meetings
Attend meetings as requested including but not limited to bid defenses, Investigator’s Meetings, face to face meeting with Sponsor.
- Demonstrates attention to detail and organizational skills
- Good time management skills, pro-active and able to manage multiple projects
- Ability to work effectively in an innovative and flexible environment.
- Solid interpersonal skills and ability to work as an effective team member and with cross-functional groups
- Excellent verbal and written communication skills
- Good public speaking skills
- Contributor to department productivity and quality goals.
- Bachelor’s Degree from a four-year college or university in Business Administration, Life Sciences or related field
- An advanced degree is preferred
- A minimum of two (2) to five (5) years of clinical research experience in Project Management, Clinical Operations, Data Management or Clinical Monitoring
- Previous experience in a pharmaceutical, CRO, or medical device company required
- Solid knowledge of ICH-GCP, local and regional regulations and guidelines for clinical research
- ISO 9001 knowledge preferred