Manager, Study Start Up
Company: Takeda Pharmaceuticals
Posted on: January 22, 2023
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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
- 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
- Establish, developing, and delivery of the Global Study Startup
- Partner with CRO's, Clinical Operations teams, and TAU partners
to improve overall study startup metrics and implement
- 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
- 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
- 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
Keywords: Takeda Pharmaceuticals, Topeka , Manager, Study Start Up, Executive , Topeka, Kansas
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