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Senior Clinical Operations Lead

Kelly Services

Cambridge, MA
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Job Details

Job Title Senior Clinical Operations Lead

Jobid US33MXMP_BH1397094

Location: Cambridge, MA, 02238, USA

Description Kelly Services has an opening for a Senior Clinical Operation Lead in Cambridge, MA. This is a one-year contract assignment. The Senior Clinical Operation Lead (Clinical Operations Lead) partners with Medical Research and other functions to develop operationally feasible and clear protocol concepts and final protocols, leverage phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy and independently oversees one or more clinical studies by establishing the operational strategy and securing excellence in execution through the CRO partner.

**Job duties:**

+ Develop scientifically robust, operationally feasible and clear protocols, and robust data monitoring plans.
+ Leverage appropriate ongoing data review to identify and mitigate patient safety, study design, data integrity or study conduct issues.
+ Ensure all operational aspects support endpoint integrity and data validity.
+ Secure operational excellence and delivery for one or more clinical studies by developing operational strategy (including ancillary vendors) aligned with the program strategy and
incorporating country input through the study Clinical Country Lead.
+ Strive for effective, consistent, efficient and compliant processes.

+ B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
+ Scientifically and clinically astute with very strong project management skills
+ Approximately 8 years of clinical research / project management experience preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations. Prior investigator site and/or monitoring experience is advantageous.
+ Deep understanding of clinical development within one or more Phases of trials (Phase II, III, IV) and a working understanding of cross functional drug development.
+ Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas.
+ Ability to establish operational plans and support the CRO in the execution of the plans.
+ Excellent project management skills with a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organization.
+ Experience in risk assessment and contingency planning.
+ Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model.
+ Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

**Perks of being a Kelly employee:**

+ Weekly electronic pay
+ Access to more than 3,000 online training courses though Kelly Learning center
+ Group rate insurance options available immediate upon hire*
+ Service bonus plan and holiday pay*
+ Online application system
+ Never an applicant fee
*perks 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** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect 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 connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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