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Associate Clinical Operations Program Leader II
Ref No.: 18-12227
Location: Cambridge, Massachusetts
Start Date / End Date: 10/15/2018 to 04/15/2019
6 contractors needed

2 for Mark Patti
2 for Heather Knowles
2 for Kraig Keeter

Position Title: Associate Clinical Operations Program Leader
Function: Translational Research & Early Clinical (TREC) or Global Development Operations
Department: Early or Late Development Operations


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 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.

ACCOUNTABILITIES:


• Accountable for planning and operational strategy for assigned clinical trials
o Provides subject matter expertise and operational input into protocol synopsis and final protocol document
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 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
• 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:
o Review and approval of key risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoring
o 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
o Study team (SET/CTWG) meeting 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
• 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.



NUMBER SUPERVISED WORKERS Direct In-Direct
Employees 0 0
Non-Employees 0 0


EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
(List the education and experience required to perform the primary responsibilities of the job. Equivalent combinations of education and experience should be noted.)

Education: 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.


LICENSES/CERTIFICATIONS:



PHYSICAL DEMANDS:



TRAVEL REQUIREMENTS:


• Requires approximately 10-20 % travel, including overnight and international travel to other sites, strategic partners, and therapeutic area required travel.