CenterWatch

17 days old

Clinical Research Project Manager (Clinical Research Scientist)

Kelly Services
West Chester, PA 19381
Kelly Services Outsourcing & Consulting Group is seeking a Clinical Research Project Manager (Clinical Research Scientist) 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 (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. 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.



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.



Knowledge of CE mark requirements 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** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-10-25 Expires: 2019-11-25

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Research Project Manager (Clinical Research Scientist)

Kelly Services
West Chester, PA 19381

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast