Manager, Study Start Up

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 Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Manager, Study Start Up based remotely reporting to the Associate Director, Study Start Up within our Clinical Site Start Up and Engagement team.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.Here, you will be an important contributor to our inspiring, bold mission.GOALS:The study startup manager defines developing and delivery of the global study startup project plan by partnering with the CRO Study Startup.

Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts.

Drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning.

Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Study Startup Services.

ACCOUNTABILITIES:Establish, developing, and delivery of the Global Study Startup Project Plan.

Partner with CRO's, Clinical Operations teams, and TAU partners to improve overall study startup metrics and implement processes.

Provide guidance, oversight, and training to the Study Startup team, delivering activities to support Clinical Programs, including data and methodologies for protocol study startup, country and site selection, study startup planning, and modeling.

Ensure standards are applied to the study startup process across project portfolios and support continuous improvement activities while developing TA-aligned strategies.

Guide the collection and analysis of all data to influence study startup timelines.

Leverage leading industry tools and data sources to provide data on startup timelines and performance (data quality, startup cycle time) to assist project teams with study initiation timeline forecasting.

Agree to deliverables on a site-level basis with the CRO and monitor adherence to these. Promptly recognize and improve potential delays, and escalate non-performance.

Lead the site activation team - internal plus CRO, using the appropriate team members to help implement the Startup Project Plan.

Drive delivery of all Takeda and CRO supported sites that are "Ready To Enroll" to the Startup Project Plan. Resolve escalated issues identified by the site activation sub-team in partnership with the Study Manager through the Study Management Operations Sub-team with the CRO.

EDUCATION AND SKILLS:BS degree or international equivalent in a life science.

5 or more years of experience in Clinical Operations, Project Management, study startup, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.

At least 3 years of direct responsibility in site identification, activation and managing the study startup processes of clinical research studies at a sponsor or CRO.

Proficiency with software models and database structures.

Ability to explain data, facilitate decision making processes to be data driven.

Expertise in principles driving country/site start-up and study start-up strategies.

WHAT TAKEDA CAN OFFER YOU:Base Salary Range: 102,000 to $146,000 . Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.EEO StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote