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Clinical Operations Program Leader - Early Phase

Kelly Services

Cambridge, MA
Job Code:
  • Business Development/Operations
  • Healthcare
  • Clinical Operations
  • Project Management
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Job Details

Job Title Clinical Operations Program Leader - Early Phase

Jobid US33MXGR_BH1443277

Location: Cambridge, MA, 02238, USA

Description Kelly Services has an opening for an **experienced Clinical Operations Program Leader in Cambridge, MA** . We are looking for **early phase** clinical operations experts with **broad experience in the strategy of early phase programs and studies** . This individual must have an early phase mindset and be comfortable in a constantly moving environment; someone who can easily adapt and change and are not afraid of the unknown since things are always changing and in flux. T **herapeutic area is GI and CNS** , prior experience in this area highly preferable. This position is budgeted through mid-November but could be temp-to-perm for the right candidate!

As a Clinical Operations Program Leader you will oversee a robust portfolio of clinical programs and their clinical studies. A typical day may include:

+ Provide operational expertise and strategic input to the development of Clinical Development Plans supporting the overall clinical strategy through to Early Proof of Concept (EPOC).
+ Develop and lead the operational strategy on assigned programs in close collaboration with our strategic partners.
+ Represent Early Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).
+ Provide sponsor’s oversight of strategic partners, program-level direction and support to ensure the effective execution of the clinical studies.

+ Accountable to the GPT for the translation of the CDP into an optimal operational plan. Ensures assessment of various scenarios for optimal execution of the CDP.

+ Partner with the Clinical Translational Scientist to develop high quality study synopsis/protocol by providing operational input and by ensuring all relevant stakeholders (both internal and external) are involved and contributing.

+ Collaborate with late phase COPL counterpart to ensure alignment and seamless interactions with the GPT.

+ Maintain close communication with the Global Program Leader to ensure expectations and activities are aligned.

+ Develop and lead the Early Clinical Program Operations strategy on assigned clinical programs in close collaboration with our strategic partners and with the CST.

+ Perform oversight of our strategic partners to ensure the overall operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.

+ Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners, including escalation of issues to governance committees and to senior management when warranted.

+ Responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works closely with strategic partners, Global Project Management (GPM), Outsourcing Management, and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate.

+ Communicates program status, cost and issues to ensure timely decision-making by senior management.

+ Provide program-level direction and support to the strategic partners for the development of study strategy operational plans including enrolment models and risk management strategy.

+ Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate.

+ Collaborate with Strategic Partners to ensure inspection readiness.

+ Bachelor’s Degree required, in Life Sciences preferred; Advanced degree is highly desirable.
+ 7+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study/project management. Experience must include early phase clinical studies/Phase 2 studies and global/international studies or programs. Experience in more than one therapeutic area is highly desired.
+ Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
+ Demonstrated excellence in project/program management and matrix leadership
+ Fluent business English (oral and written)
This position is on-site in Cambridge, MA and may require approximately 5-20% travel, including overnight and international travel.

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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