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25 days old

Sr. Clinical Operations Manager

Kelly Services
Cambridge, MA 02238
Kelly is seeking a **Sr. Clinical Operations Manager** for one of our biotech clients


+ 1 year contract

+ remote

+ $90-123/hr


OBJECTIVES:


Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.

In close collaboration with Clinical Operations Program Lead(s)

Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.

Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takedas obligations described in ICH-GCP and Takedas business objectives.

The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.


ACCOUNTABILITIES:


Accountable for planning and operational strategy and execution for assigned clinical trials

o Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents

o Challenges study team to ensure operational feasibility, inclusive of patient and site burden

o Validates budget and ensures impacts are adequately addressed

o Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy

o Challenges study team to ensure timelines meet the needs of the clinical development plan

o Ensure new team members and vendors are appropriately onboarded

During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place

Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly

Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs

Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;

Specific areas of sponsor oversight include, but are not limited to:

o Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring

o Review and endorsement of relevant study plans, as applicable

o Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes

o Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study

o Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies

In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.

Ensure studies are inspection ready at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.

Represent the Clinical Operations Manager role in functional initiatives or working groups.

Help with onboarding and mentoring of new or junior COMs.

May assist the program COPL in his/her role, as required.


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:


Education: Bachelors Degree or international equivalent required, Life Sciences preferred.

Skills:

Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.

Demonstrated excellence in project/program management and matrix leadership

Excellent communication skills

Excellent teamwork, organizational, interpersonal, and problem-solving skills

Fluent business English (oral and written)

Experience: 6+ years experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.


TRAVEL REQUIREMENTS:


Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-28 Expires: 2021-06-28

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Sr. Clinical Operations Manager

Kelly Services
Cambridge, MA 02238

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