Senior Manager, Study Start Up (remote)
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 8, 2022
Job Description:
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionSenior Manager, Study Start UpAre 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.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.
- 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 ProgramsLocation 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 ShineDiscover more at takedajobs.comNo Phone Calls or
Recruiters PleaseEEO 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
Keywords: Takeda Pharmaceutical, Cherry Hill , Senior Manager, Study Start Up (remote), Executive , Cherry Hill, New Jersey
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