Kelly Services Associate Clinical Operations Program Leader in Cambridge, Massachusetts
Kelly Services is currently seeking an Clinical Operations Program Leader to work a high-level contract 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.
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 Leads
Responsible for oversight of 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.
Oversight of 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 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 for assigned clinical trials
Provides subject matter expertise and operational input into protocol synopsis and final protocol document
Challenges study team to ensure operational feasibility, inclusive of patient and site burden
Validates budget and ensures impacts are adequately addressed
Participates in country and site selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
Challenges study team to ensure timelines meet the needs of the clinical development plan
With Strategic Partner(s) and/or other CROs, support 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 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 Leader(s) ; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
Oversight of 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:
Review and approval of key risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoring
Review and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at the study level
Study team (SET/CTWG) meeting attendance when necessary; regular review of meeting agendas and minutes
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
Documented review and monitoring of issues, risks and decisions at the study level
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.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor’s Degree or international equivalent required, Life Sciences preferred. Skills:
Expertise 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 teamwork, organizational, interpersonal, and problem-solving skills
Fluent business English (oral and written)
Experience: 5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management strongly preferred. Experience must include 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.
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 relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a 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 kellyservices.com and connect
with 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 is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.