Kelly is currently seeking a Medical Device Post-Market Clinical Project Manager/Clinical Research Scientist for an on-going opportunity to work for one of the largest well known Global medical device companies in the world.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
The Post-Market Clinical Project Manager/Clinical Research Scientist will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements.
The Post-Market Clinical Project Manager/Clinical Research Scientist will:
• Manage, Initiate and Execute timely on strategic plans and deliverables for Post-market Clinical Follow-up (PMCF)
• Develop and draft Post-market Clinical Follow-up plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal supervision.
• Lead PMCF study start-up, and ongoing oversight
• Oversee and manage sites participating in PMCF
• Support Clinical MDR activities & deliverables
• Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market evidence generation strategies that consider global evidence needs and product lifecycle.
• 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 orthopedic 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.
• Supports budget development and management of clinical projects
• Responsible for complying with all company procedures
• Maintain strong understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation).
• A Bachelor’s degree in Biological/Biomedical 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.
• Experience working in clinical research and/or regulatory affairs in Orthopedics and/or Sports Medicine is preferred
• The ability to travel domestically up to 5% is required.
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Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.