Clinical Research Project Manager

Medical Device Temporary/Freelance 05.02.2019

I’m looking for a Clinical Research Project Manager (Clinical Research Scientist) for the largest, most innovative and comprehensive orthopedic and neurological business in the world. In this role the main responsibility is the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements. The duration of the project is at least 1 year, and the location is Oberdorf.

I’m looking for a Clinical Research Project Manager (Clinical Research Scientist) for the largest, most innovative and comprehensive orthopedic and neurological business in the world. In this role the main responsibility is the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements. The duration of the project is at least 1 year, and the location is Oberdorf.
RESPONSIBILITIES

  • 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.
  • Develop a strong understanding of the orthopaedic 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.

PROFILE

  • A Bachelor’s degree in Biological Science or related discipline, with a minimum of 4 years related scientific, technical, or clinical research experience
  • Experience in the Medical Device industry
  • Understanding of Good Clinical Practices
  • Technical writing skills
  • Project management experience
  • Good communication and team work skills
  • Previous experience developing strategies to generate clinical evidence is preferred
  • Understanding and application of US and EU regulations and standards applied to medical device clinical research is preferred
  • Ability to travel domestically up to 5%

START DATE

ASAP (flexible)

DURATION

1 year (with a high possibility for extension)

INTERESTED?

If you’re interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.

For further information, please contact Nora Bede at +31 (0)20 20 44 502 or by email at n.bede@panda-int.com

PANDA INTERNATIONAL is a specialist recruitment agency dedicated to placing high-level candidates in freelance and temporary roles within the Pharmaceutical, Medical Device, Biotech and Food sectors across Europe. By working closely with candidates and companies in meeting challenging business demands, the Panda team has developed an extensive client base consisting of the world’s leading Life Sciences organizations.

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