Clinical Research Project Manager

Highly Competitive
  1. Permanent
  2. Clinical Research Associate (CRA), Project/Study Manager (CSM/CPM), Program Manager / Director
  3. Switzerland
Basel
Posting date: 04 Feb 2019
CR.SB.21552_1549297146

ProClinical is happy to advertise an opportunity for a Clinical Research Project Manager position for one of the leading workforce management solutions companies in the world, that specialises in multiple scientific and engineering sectors. This position is based in the company's Swiss team in Basel.

The Clinical Research Project Manager will be responsible for the development of post-market clinical research strategies of orthopaedic devices to support global regulatory and post-market surveillance requirements.

Job Responsibilities:

  • Working closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post-market evidence generation strategies that consider global evidence needs.
  • Maintaining strong understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation).
  • Developing and drafting Post-Market Clinical Follow-Up (PMCF) plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal supervision.
  • Fostering relationships with surgeons, hospitals, and research teams to gain input not study design, evaluating study feasibility, and identifying sites for study execution or data collection.
  • Developing 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.
  • Partnering with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.
  • Drafting 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.
  • Supporting clinical scientific discussions with regulatory agencies/notifying bodies to drive support of the clinical and regulatory strategy and communicating evidence.
  • Contributing to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports.
  • Ensuring study registration requirements are met.
  • Developing a strong understanding of the orthopaedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.
  • Keeping management up-to-date regarding key developments and issues that impact clinical strategy and portfolio management.
  • Demonstrable ability to build collaborative relationships with key internal and external partners and stakeholders.

Skills and Requirements:

  • A bachelor's degree in a Biological Science field, or related discipline.
  • At least 4 years of scientific, technical, or clinical research experience.
  • Previous experience in the Medical Device industry.
  • A demonstrable track record of success managing multiple projects simultaneously with minimal supervision.
  • A thorough understanding of Good Clinical Practices is required.
  • Understanding and applying US and EU regulations and standards applied to medical device clinical research is preferred.
  • Strong problem solving, persuasion, and negotiation skills; being able to execute solutions/deliverables in a timely manner.
  • An ability to establish rapport quickly, with a demanding and expert client base.
  • Excellent written and oral English skills, with other European languages a bonus.
  • A proven ability to focus and work with attention to detail, along with retaining critical information.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sasha Brasero on +44 203 078 9556 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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