Senior Manager, Study Start Up
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Manager, Study Start Up in Cambridge, MA or remotely reporting to the Director, Feasibility and Study Start Up.
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.
- 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.
- 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.
- Be a role model for Takeda's values
- The Senior Manager, Study Start Up will oversee and ensure the delivery of global (end-to-end) study startup activities (strategy, plans, activities, timelines, and synthesis of study startup insights and presentation to study teams) at program/study level.
- Help study teams to conduct and ongoing delivery within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals.
EDUCATION AND SKILLS:
- BS degree or international equivalent in a life science.
- 8 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 5 years of direct responsibility in site identification, activation and managing the study startup processes of clinical research studies at a sponsor or CRO.
- Expertise with leading edge trial optimization vendors, tools and methods.
- Proficiency with software models and database structures.
- Expertise in principles driving country/site identification, study startup and study startup strategies.
- Experience driving unbiased data insights into clinical trials operational planning.
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: $165K-$180K 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
Discover more at
No Phone Calls or Recruiters Please
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
Massachusetts - Virtual Worker Type
Employee Worker Sub-Type
Regular Time Type