Job details
Salary $120,000 - $140,000 a year job type full-time
Full job description
By clicking the “apply” button, i understand that my employment application process with takeda will commence and that the information i provide in my application will be processed in line with takeda’s privacy notice and terms of useI further attest that all information i submit in my employment application is true to the best of my knowledge.
Job description
Clinical operations manager
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 takedaJoin us as an clinical operations manager in our cambridge/lexington office or remote.
Here, everyone matters and you will be a vital contributor to our inspiring, bold missionAs a clinical operations manager 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:
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 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 of low to medium level of complexityMore 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
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 executionWorks 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.
Education, experience, knowledge and skills:
Education: bachelor’s degree or international equivalent required, life sciences preferredAdvanced degree(s) (i.eMaster or doctorate) and relevant training or experience (i.eFellowships, internships etc.) may be considered to supplement experience requirements.
Skills:
Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to us cfr, eu ctd, and ich gcpAwareness of local country requirements is also required.
Demonstrated successful experience in project/program management and matrix leadership
Good communication skills
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 managementExperience must include either early phase clinical studies or phase 2 and 3 studies and global/international studies or programsExperience in more than one therapeutic area is advantageous.
Physical demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this jobReasonable 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.eComputers, phones, etc.
Travel requirements:
Requires approximately 5-20 % travel, including overnight and international travel to other takeda sites, strategic partners, and therapeutic area required travel
What takeda can offer you:
401(k) with company match and annual retirement contribution plan
Tuition reimbursement
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
Location and salary information:
Location(s): remote
Base salary range: $120k-$140k based on candidate professional experience level.
“this posting is made in compliance with colorado’s equal pay for equal work act, c.r.s§ 8-5-101 et seq.”
Empowering our people to shine
Learn more at takedajobs.com.
No phone calls or recruiters please.
Eeo statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, ma
Worker type
Employee
Worker sub-type
Regular
Time type
Full time
