10 days old

Senior Project Manager of Clinical Research, Atlanta, GA Area

Kelly Services
Durham, NC 27722
Kelly Services is currently hiring a **Senior Project Manager of Clinical Research** for a **DIRECT HIRE** position in **Atlanta, GA** . **This is a full-time direct hire role with benefits and relocation assistance** .


+ **MUST have 4 6 years of industry experience in the medical/biomedical industry**

+ **MUST Have Phase III Clinical Study experience**

+ **Candidates holding experience with cardiovascular med devices or stents will be shown preference**

+ **MUST HAVE experience with clinical trials from the sponsor perspective**

+ **MUST HAVE experience managing a clinical project team**

+ **CRA Certification or Certification Eligible**

**Job Responsibilities:**

+ Develop clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc. as needed. Prepare status reports, as required.

+ Liaison between investigational sites, and CROs (as applicable) to coordinate and document clinical research studies. Respond to written and telephone inquiries from investigational sites, as applicable.

+ Collect, query, analyze, and present clinical data. Develop and maintain any applicable clinical research databases as necessary.

+ Identify required biocompatibility testing, work with legal to develop a contract and ensure timely completion and accuracy of final report.

+ Conduct basic statistical analyses for technical support of product line.

+ Conduct literature reviews and write research summaries related to product line.

+ Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.

+ Prepare product Instructions for Use and assist with labeling and labeling changes (including receipt of applicable translations).

+ Generate final clinical study reports.

+ Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.

+ Evaluate and report on adverse events, complaints, and failures associated with the product line.

+ Attend surgical congresses as necessary.

+ Complete necessary product Clinical Evaluation Reports and/or any other reports necessary to support regulatory submissions.

+ Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) marketing literature.

+ Responsible for site recruitment/selection, investigator meetings, and management of clinical study sites.

+ Ensure that clinical trials are conducted in accordance with applicable standards and regulations.

+ Oversee project budgets, budget change forms, accruals, and monthly reports.

**Job Requirements:**

+ Minimum 4-6 years experience, within the medical/biomedical industry.

+ Experience managing a clinical project team and Phase III clinical studies

+ BS in biological science, epidemiology, engineering, statistics, or other science-related field.

+ Non science degrees are also welcome to apply


+ Competitive salary with career advancement opportunities

+ Medical

+ Wellness Incentives

+ Dental Plan

+ Flexible Spending Account

+ 401K

+ Employee Stock Purchase Plan

Apply Today for Immediate Consideration!

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

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing 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 95 of the Fortune 100 companies, and found opportunities for more than 9,000
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.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit 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.
Posted: 2019-01-11 Expires: 2019-02-11

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Senior Project Manager of Clinical Research, Atlanta, GA Area

Kelly Services
Durham, NC 27722

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