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1+ months

Medical Device Project Manager

Kelly Services
West Chester, PA 19381
Kelly Services Outsourcing & Consulting Group is seeking a Clinical Research Project Manager for a long-term, open-ended opportunity in West Chester, PA. This opportunity will be supporting our customer who develops minimally invasive devices and early intervention products used in the treatment of joint injuries related to sports and physical activity as well as degenerative tissue conditions.



The Clinical Research Project Manager will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements. Ideal candidates will have experience developing clinical evidence strategies, practical experience could include interactions with regulatory bodies, protocol development, publication strategy development / execution etc.





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 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.





Qualifications:



A Bachelors 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; experience writing CERs.



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.



Knowledge of EU MDR and CE mark requirements.



Understanding and application of US and EU regulations and standards applied to medical device clinical research is preferred.



Experience developing strategies to generate clinical evidence highly preferred.



Sports medicine background highly preferred.





If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!





This position comes with enhanced benefits which include:



50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%) *



Paid sick days and vacation days*





Perks of being a Kelly employee:



Weekly electronic pay



Access to more than 3,000 online training courses though Kelly Learning center



Online application system



Never an applicant fee





*benefits to be received upon meeting eligibility requirements





Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


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.

\#KellyGTS

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Posted: 2019-12-09 Expires: 2020-03-21

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Medical Device Project Manager

Kelly Services
West Chester, PA 19381

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