Kerecis (www.kerecis.com) is a biotechnology company that develops, manufactures and markets regenerative grafts from Omega3-rich fish skin. The company’s initial product (Kerecis Omega3 Wound) has been approved by the FDA and is being marketed in the U.S. and international markets.
Kerecis seeks a highly motivated and experienced Multicenter Clinical Trial Project Manager to support its Clinical Development department and European market efforts. Projects will require an understanding of the legal environment surrounding medical products and multicenter clinical trials. As Project Manager, you will ensure the success, timeliness and cost-effectiveness of projects. This means you understand the steps required to prepare, execute and govern clinical trials, and you will be able to conduct constructive follow-up evaluation to link results with market potential.
The Project Manager supervises monitors and supports the administration and progress of clinical trials at multiple institutions on behalf of the lead Principal Investigator. The Project Manager serves as the primary client contact for the project and is responsible for the project's success. If you have significant clinical research experience, are able to operate independently and with little supervision, and can lead teams over which you exercise no formal supervision, then you will be a great addition to the team.
The Project Manager will ideally be located in the Zurich, Switzerland, office as a part of the Clinical Development team and will report directly to the VP of Clinical Development based in Reykjavik, Iceland.
• Develop systems and processes necessary for the recruitment, tracking, planning and execution of projects.
• Initiate and maintain client relationships for ongoing and prospective projects.
• Oversee the development of project proposals and budgets and approve for submission to clients.
• Analyze short- and long-term resource needs and adjust staffing and resources appropriately.
• Ensure completion of deliverables and adherence to timelines.
• Track projects and allocate necessary work flow, personnel and financial resources.
• Analyze and resolve issues that might jeopardize performance.
• Ensure successful financial performance of projects.
• Proactively identify changes in scope of work and ensure measures are taken with internal and external clients to reassess, renegotiate and amend proposals, contracts and budgets.
• Ensure projects are commercially valuable.
• Engage in communication and change management in relation to progress of projects.
• Proficiency in English and two of the following; German, French and/or Italian
• Proven experience as a project manager, especially for clinical trials
• Outstanding communication and negotiation ability
• Ability to write scientific reports in English
• Computer savvy; proficient in MS Office
• Excellent organizational skills
• A knack for problem-solving
• A team player with leadership skills
• Must be able to travel
Education & Experience
• Bachelor's degree required.
• At least four to seven years of clinical research experience. Relevant experience may be considered in lieu of a degree.
• One of the following is required: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), Certified Clinical Research Profession (CCRP), or Certified Clinical Project Manager (CCPM).
• Project Management Institute (PMI) certification is preferred.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.