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9 days old

Clinical Research Scientist

Kelly Services
West Chester, PA 19381
Kelly Services Outsourcing & Consulting Group is seeking candidates for a Clinical Research Scientist for a one-year, with strong potential to extend, position based in West Chester, PA. On behalf of the Medical Device Group, this clinical research professional will be responsible for the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects with limited supervision.







Job duties of the Clinical Research Scientist include:




+ Contribute to the development and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms. This is accomplished with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access).

+ Ensure input and strong alignment from key regional MD Clinical R&D leads and other strategically important countries/regions in the development of the EGS / EDS.

+ Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision.

+ Plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements

+ Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP).

+ 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.

+ Draft study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions.

+ Responsible for critically assessing the literature and drafting Clinical Evaluation Reports (CERs) for new products.

+ Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc. including during sponsor regulatory inspections.

+ Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data/evidence for market access and reimbursement;

+ Foster strong relationships with key investigators to deliver evidence.

+ Ensure registration on www.clinicaltrials.gov from study initiation through posting of results.

+ Develop a strong understanding of the pipeline, product portfolio and business needs.

+ Keep management informed of key developments and issues that impact clinical strategy and portfolio management.

+ May be involved in other tasks to support clinical research activities as needed.







**Functional and Technical Competencies:**






+ Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;

+ Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects;

+ Proven track record in delivering clinical projects within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;

+ Ability to lead study teams to deliver critical milestones;

+ Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.) and to meet business objectives;

+ Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders;

+ Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times;

+ Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer;

+ Performs other related duties as required.





**Education & Experience Requirements:**




+ A Bachelors or equivalent degree in Biological Science or related discipline

+ A minimum of 6 years related scientific / technical / clinical research experience





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 holidays

+ 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. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.**






**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

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Posted: 2018-12-05 Expires: 2019-01-05

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Clinical Research Scientist

Kelly Services
West Chester, PA 19381

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