Innovation Project Management Leader [Remote]

Environmental Conditions
Office
Join Us as a Senior Project Manager - Make an Impact at the Forefront of Innovation. Lead or support study operational strategy and planning and oversee execution of select clinical studies (global/regional and/or local country) for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
In close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable):
Support or oversee the execution of select study/ies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Client SOPs), on schedule and on budget.
Studies may include but are not limited to PTA (Post Trial Access), RATIO (R&D Asset Transition and Integration Office), those in wind down, etc. Accountable for planning and operational strategy and execution for assigned clinical trials
Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
Challenges study team to ensure operational feasibility, inclusive of patient and site burden
Participates in country and site feasibility/selection process, with a focus on providing country insights, alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
Develops and manages study timelines
Identifies and oversees trial risk and mitigation
Leader of the cross functional study team
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
Supports/reviews study budget planning and management and accountable for external spend related to study execution. Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; serve as escalation point for all 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;
Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
Conduct Oversight Monitoring Visits, as applicable
Study team meeting management and attendance when necessary; 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 and implementation of appropriate mitigation strategies
Review and ownership of trial operational data (e.g. In partnership with data management, review and pressure test all database timelines and plans; filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
Support data review for database lock and CSR writing and review (including appendices)
Collect/review/File study documents in support of the trial master file (TMF)
Collect/review/File study documents in support of the regulatory filing
Responsible for overseeing study financial reconciliation
Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
Site relationship management
Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations

Bachelor’s Degree or international equivalent required; 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 successful experience in project/program management and matrix leadership
E.g. timeline/budget management
Risk identification and management
Experience managing recruitment challenges and boosting enrollment
Fluent business English (oral and written)

Experience: 8+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA). 2+ years of experience in global lead project management field. Oncology experience is required (as lead PM or Lead CTM). Extensive ICF experience required (on a country and site level). Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Master or Doctorate) and relevant training or experience (e.g., When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. Apply today to help us deliver tomorrow’s breakthroughs.