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Clinical Operations Lead

Kelly Services

Cambridge, MA
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Job Details

Job Title Clinical Operations Lead

Jobid US41L7KR_BH1431576

Location: Cambridge, MA, 02238, USA

Description **Job Title: Clinical Operations Lead**

**Job Responsibilities**

• Actively leads a highly performing CDT. Ensures appropriate strategic topics are discussed and managed
• Collaborates with Core CDT members to ensure that the program has an Clinical Development Plan (CDP) that meets the strategic objective of the asset plan and has been updated and approved by appropriate approval/governance bodies at appropriate time points
• Leads through influence and effectively communicates/collaborates in a highly matrixed organization
• Is responsible for the development and execution of the clinical development plan (CDP) In conjunction with the Lead MD for the program. Contributes to the development of CDP and IDP/asset plan from both a strategic (eg key decision points and risk, study scenario planning) and operational perspectives (eg study timelines and financials)
• Represents CDT and GCO as a key Program Team Member
• In conjunction with Lead MD responsible to report on the status of the CDP and
• May interface with to key external stakeholders representing the program (KOL’s, advocacy groups, partners etc)
Operational Leadership
• Provides high level oversight of the individual studies in the CDP (matrix leadership of the Clinical Operations Leads (COL)/ Study Management Team (SMT ) and ongoing review to ensure adherence with key parameters (eg, time, cost, quality) of the CDP
• Accountable for operational delivery of all studies within the CDP through the program lifecycle (from planning, execution, data delivery and inspection planning and support activities)
• Leverages deep operational expertise to develop comprehensive program level strategy that complements the indication, science and strategic intent of the CDP
• Collaborates with key stakeholders internally and externally to understand the global therapeutic landscape. Leverages this knowledge for the benefit of the program (eg establishing geographic recruitment strategies)
• Contribute to ongoing process improvement and department initiatives within CPL and GCO
**Skills and Experience Requirements**

• Proven ability to lead effectively in a matrix environment
• Management or Sr. Level experience in biotech or pharma industry with strong preference for candidates with at least 2-3 years of experience in a similar role who have the ability to operate with a high level of independence and minimal oversight
• Demonstrated drug development expertise that includes participation in or leading CDP strategic planning and timing
• Strong track record of clinical operations experience (planning, oversight of programs and studies as well as vendor delivery), in a management level role
• Superior communication skills, high level of professionalism in this highly visible role with proven ability communicate credibly to stakeholders of all levels across multiple disciplines.
• Successful candidates will be self-starters and highly motivated with the ability to adapt to changing priorities in a fast-paced environment

***Additional Details***

1. Contract Length: 12 months
2. Pay Rate: Determined by experience
Please email your resume to to be considered for this opportunity. Thank you!

**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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