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Clinical Research Project Manager
Ref No.: 18-02948
Location: West Chester, Pennsylvania
Start Date: 03/19/2018
The Clinical Research Project Manager (Clinical Research Scientist) will be responsible for the development of post-market clinical research strategies of Clientpedic devices to support global regulatory and post-market surveillance requirements.
The Clinical Research Project Manager (Clinical Research Scientist) will:
  • Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market evidence generation strategies that consider global evidence needs.
  • Maintain strong understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation).
  • Develop and draft Post-market Clinical Follow-up (PMCF) plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal supervision.
  • Foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection.
  • Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.
  • Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
  • Draft Post-Market Clinical Follow-up (PMCF) Reports and study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for regulatory submissions.
  • Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, and communicate evidence.
  • Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR),
  • Ensure study registration requirements are met (i.e. clinicaltrials.gov).
  • Develop a strong understanding of the Clientpedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
  • Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
  • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.

Qualifications:
  • A Bachelor's degree in Biological Science or related discipline, with a minimum of 4 years related scientific, technical, or clinical research experience.
  • Previous experience in the Medical Device industry is required.
  • Advanced technical writing skills is required.
  • Demonstrable track record of success managing multiple projects simultaneously with minimal supervision is required.
  • Ability to communicate effectively and work with teams is required.
  • Previous experience developing strategies to generate clinical evidence is strongly preferred.
  • Understanding of Good Clinical Practices is required.
  • Understanding and application of US and EU regulations and standards applied to medical device clinical research is preferred.
  • The ability to travel domestically up to 5% is required