Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Clinical Operations Manager in our Cambridge/Lexington office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Program Leader working on the Clinical Operations team, you will be empowered to 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, and a typical day will include:
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 Takeda SOPs), on schedule and on budget.
Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda's obligations described in ICH-GCP and Takeda's 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
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
Validates budget and ensures impacts are adequately addressed
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
Challenges study team to ensure timelines meet the needs of the clinical development plan
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:
Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
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
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, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education: Bachelor's 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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to sit and stand for long periods of time.
Carrying, handling and reaching for objects.
Manual dexterity to operate office equipment i.e. computers, phones, etc.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.
Takeda Pharmaceutical Company Ltd