25 days old

REMOTE Sr. Clinical Operations Manager-Late phase oncology required

Kelly Services
Cambridge, MA 02238 Work Remotely
**Kelly Services** is currently seeking a **REMOTE Sr. Clinical Operations Manager** in **Cambridge, MA** to work a contract assignment 6 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities of the (Job Title) includes:**


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 SOPs), on schedule and on budget.

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


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


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.


**For immediate consideration, please send your resume in a WORD document to**

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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. 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.



Posted: 2020-07-10 Expires: 2020-08-10

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REMOTE Sr. Clinical Operations Manager-Late phase oncology required

Kelly Services
Cambridge, MA 02238

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