Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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):
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. 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
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
Supports budget development and ensures impacts are adequately addressed
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
Challenges study team to ensure timelines meet the needs of the clinical development plan
Ensures new team members and vendors are appropriately onboarded
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
Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly
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; Communicates study status, cost and issues to COM and COPL; 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;
Specific areas of sponsor oversight include, but are not limited to:
Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
Conduct Oversight Monitoring Visits, as applicable
Review and endorsement of relevant study plans, as applicable
Study team meeting management and 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 and implementation of appropriate mitigation strategies
Review and ownership of trial operational data (e.g. CTMS)
Review and provide oversight of internal trial reports
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.
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
Review and provide oversight of trial audits
Proper and timely follow up to audit findings and CAPAs
Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education: Bachelor's 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 successful experience in project/program management and matrix leadership
E.g. timeline/budget management
E.g. Risk identification and management
Works independently and is highly organized
Good communication skills
Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with Leading cross-functional teams, vendor selection and oversight
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. Experience in more than one therapeutic area is advantageous.
Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.