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9 days old

Clinical Research Project Manager

Kelly Services
West Chester, PA 19381
Clinical Research Project Manager West Chester, PA. Do you have experience working in Clinical Research and the Medical Device Industry? Kelly Scientific Resources currently has a long-term contract (2+ years) position available for a Clinical Research Project Manager in the West Chester area with a well-known research facility. The ideal candidate will be able to work individually and with a team, have strong organizational skills, and be able to multi-task.



Tasks/Services:




+ 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.



Requirements:




+ 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

+ Advanced technical writing skills

+ Demonstrable track record of success managing multiple projects simultaneously with minimal supervision

+ Ability to communicate effectively and work with teams

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

+ Understanding of Good Clinical Practices

+ Understanding and application of US and EU regulations and standards applied to medical device clinical research

+ The ability to travel domestically up to 5% is required






**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: 2018-12-05 Expires: 2019-01-07

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Clinical Research Project Manager

Kelly Services
West Chester, PA 19381

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