Senior Manager, Study Start Up (remote)
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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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
The study startup manager defines developing and delivery of the
global study startup project plan by partnering with the CRO Study
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
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
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.
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
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
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
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
Location and Salary Information:
Base Salary Range: $165K-$180K based on candidate professional
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 takedajobs.com
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.
Massachusetts - Virtual
Keywords: Takeda Pharmaceutical, Bethlehem , Senior Manager, Study Start Up (remote), Executive , Riegelsville, Pennsylvania
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