Associate Director, Study Start Up
Company: Takeda Pharmaceutical
Posted on: November 21, 2022
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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 an Associate Director, Study Start
Up based in Cambridge, MA or remotely reporting to the Head of Site
Startup.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, 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 deliver 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 Associate Director, Study Startup
is responsible for line management of assigned Study Startup staff,
and delivering of the global study startup project plan by
partnering with the CRO on Study Startup:
- Provide guidance to staff and oversee the analysis of clinical
trial intelligence data and its application to conduct accurate
study startup forecasts, scenarios, and accurate planning.
- Directly support priority or complex projects through the study
- Promote the creation and implementation of creative processes,
methodologies, data and technologies that will ensure ongoing
delivery of valued Study Startup Services.ACCOUNTABILITIES:
- Responsible for line management, mentoring, and development of
assigned Study Startup staff.
- Deliver the Global Study Startup Project Plan.
- 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, creating activities to support Clinical Programs, including
data and methodologies for protocol study startup, 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 creation and implementation of solutions to improve
processes and accelerate 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 fix potential delays, and escalate
- Lead the site activation team (internal and CRO) using the
appropriate team members to help implement the Startup Project
- Serve as point of escalation and help resolve issues identified
by Takeda or CRO staff during the startup process.EDUCATION AND
- Bachelor's degree or international equivalent in a life science
required, advanced degree preferred.
- 8 or more years of experience in Clinical Operations, Project
Management, study startup, or trial optimization with evidence of
increasing responsibility within a pharmaceutical company, CRO or
relevant industry vendor required.
- More than 5 years of direct responsibility in site management,
activation and oversight of the study startup process of clinical
research studies at a sponsor or CRO Experience in line management
and working in a matrix environment.
- Expertise with leading edge trial optimization vendors, tools,
- Proficiency with software models and database structures.
- Expertise in principles driving study startup and site startup
- Demonstrate, interpret, explain, represent, and lead unbiased
data insights into clinical trials operational planningWHAT TAKEDA
CAN OFFER YOU:
- This position is currently classified as "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
- In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.
- Base Salary Range: $180,000 - $200,000, based on candidate
professional experience level.
- Employees may also be eligible for Short Term and Long-Term
Incentive benefits as well.
- 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.
- 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
Keywords: Takeda Pharmaceutical, Weymouth , Associate Director, Study Start Up, Executive , Weymouth, Massachusetts
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