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12 days old

Clinical Research Scientist

Kelly Services
Somerville, NJ 08876
**Seeking a Clinical Research Scientist for a 12 month assignment.**




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


The Clinical Research Scientist will:


Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to identify evidence gaps and develop post market evidence generation strategies that consider global evidence needs.

Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.

Maintain strong understanding of evolving post-market evidence requirements (i.e. FDA and EU Medical Device Regulation).

Draft and develop Post-market Clinical Follow-up (PMCF) plans, clinical study protocols, registry plans, informed consents, investigator brochures, and other study materials with minimal supervision.

Manage all operational aspects of assigned PMCF plans.

Plan, track, and manage assigned PMCF budgets to ensure adherence to business plans

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.

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 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 is required.

Demonstrable track record of success managing multiple projects simultaneously with minimal supervision is required.

Ability to communicate effectively and work within a matrix environment is required.

Understanding of Good Clinical Practices is required.

Previous experience developing strategies to generate clinical evidence is strongly preferred.

Previous experience in the Medical Device industry is preferred.

Advanced technical writing skills is preferred.

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



**APPLY NOW!**



**For immediate consideration, please send your resume to gaut985@kellyservices.com**






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-01-10 Expires: 2020-02-10

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Clinical Research Scientist

Kelly Services
Somerville, NJ 08876

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