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Clinical Project Manager

3 months ago

Bedford, United States Pramand LLC Full time
Job DescriptionJob DescriptionSalary:

About Rejoni:

Rejoni is a Pramand portfolio company based in Bedford, MA.   We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy.  Rejoni has developed a hydrogel implant to minimize intrauterine adhesions.  We self-fund our projects through preclinical development and work with financial partners for clinical development and commercialization.  Our portfolio of hydrogel technology positions us to be the leader in creating new hydrogel based medical devices to address unmet medical needs in a range of surgical interventions.  We have launched over ten medical device companies based on this unique technology.  These companies have generated over $4B in value, and have helped over 5 million patients worldwide achieve better outcomes.


Position Summary:

The Clinical Project Manager (CPM) leads the planning, coordination, and oversight of scheduled clinical activities. This position will manage the implementation of the clinical operational plans in alignment with the Sponsor’s strategic objectives and in accordance with regulatory guidelines and Good Clinical Practice (GCP).  The individual will be responsible for effective global management of relationships and establishes strong partnerships with external team/vendors activities, including investigational sites, contract research organizations (CROs), central labs, Institutional Review Board (IRB), Sponsors and other external partners.


Principle Duties & Responsibilities:

  • Maintain detailed daily coordination and supervision of scheduled and ongoing projects
  • Serve as main point of contact for clinical operations study activities both internally and externally
  • Work collaboratively with cross-functional teams to define and discuss operational strategies, proactively identify potential efficiencies and contingency plans to ensure the trial is executed successfully and on time
  • Prepare project-specific Request for Proposal materials, review vendor specifications, and recommend vendor selection
  • Develop and implement operational plans while ensuring compliance with current regulatory guidance and GCPs
  • Lead the development of integrated study timelines through collaboration with internal and external stakeholders
  • Manage aspects of trial operations, including vendor performance, metrics for key quality indicators, and communication of trial status within and outside the trial team
  • Prepare and maintain assigned program and internal files
  • Manage vendors to Scope of Work (SOW), quality, and budget towards successful achievement of study goals
  • Regularly meet with Clinical Operations Management to discuss overall clinical trial(s) status, update forecasting, and potential issues or recommendations; ensure proper and timely escalation of critical issues
  • Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, trial reports, and annual reports
  • Oversee activities associated with routine and advanced trial start-up, conduct and closeout activities to industry and corporate standards and goals
  • Review and approve vendor invoices and manage accruals and Statement of Work (SOW) changes
  • Conduct site-level training
  • Assist with the qualification and validation of company-utilized systems
  • You will be required to travel to study sites, investigator meetings, and attend in-person meetings at the Rejoni/Pramand office (up to 20% of time domestic travel)


Qualification Requirements

Education:

  • Bachelor’s degree in life sciences or equivalent training/experience

Experience:

  • Minimum of 5 years of experience in clinical trial management in a CRO or bio-pharma setting.
  • Minimum of 3 years of experience as a PM

Knowledge & Skills:

  • Two years of experience in managing vendors
  • Demonstrated knowledge of FDA/GCP/ICH guidelines
  • Experience with Quality Assurance capabilities preferred
  • Willingness to work in a dynamic and changing environment

Working Conditions:

  • Long periods of time sitting or standing at a computer
  • Domestic travel up to 20% of the time for site visits and investigator meetings