Clinical Project Manager
Agility Personnel Rockville, MD
- Expired: over a month ago. Applications are no longer accepted.
Seeking Clinical Project Manager in Maryland (preferred). Can work remotely if in same time zone (required).
The clinical project manager is a member of a matrix team dedicated to the implementation of clinical research studies and development of programs and clinical trials. CPM is responsible for managing all assigned clinical projects and also supporting regulatory affairs, data management, medical writing, biostatistics, medical affairs to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines, Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
Duties and Responsibilities:
- Demonstrating outstanding scientific knowledge applicable to clinical research and the highest personal and ethical standards
- Track project performance, site level progress to ensure all projects are delivered on-time, within scope and budget
- Responsible for the overall management of assigned clinical trials from start up phase through close out activities
- Develop clinical Standard Operating Procedures (SOPs)
- Responsible for preparation of clinical operation documents and study plans (PMP, CMP etc)
- Lead site contract and budget negotiations and implementation
- Review monitoring trip reports completed by CRAs
- Communicate with sponsor team members and third-party vendors and organize project meetings with cross-functional groups
- Plan and participate in Investigator Meeting
- Contribute to discussions with regulatory authorities and other scientific experts if needed
- Provide clinical related training for R&D team members and/or other department members
- Continually developing knowledge and skill to strengthen job performance
- Maintaining the highest standard in complying with the company regulations and behavior standards.
- Engage in open and honest communication
- Handling sensitive and confidential information with tact, discretion and judgment
- Performing other related duties as required and assigned
Bachelors and/or masters degree in a scientific discipline
- Global trial management experience is preferred.
- Therapeutic area includes cardiovascular, CNS, oncology is preferred.
- Minimum of 6 years clinical research experience as clinical project manager/project lead in the CRO company is required.
- Solid understanding of FDA and other regulatory requirements
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Project Management Professional (PMP) certification is a plus
- Strong interpersonal and communication skills
- Proficiency with MS Office suite (word, excel, PowerPoint, and outlook)
- Working knowledge of MS Project for development and update of clinical study timelines
- Willing to travel up to 10%-20% if required.
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