Senior Clinical Trial Associate/Lead Clinical Trial Associate
Company: Takeda Pharmaceuticals
Posted on: November 26, 2022
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to the best of my knowledge.Job DescriptionSenior Clinical Trial
Associate/Lead Clinical Trial AssociateAre you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as a Senior Clinical Trial
Associate/Lead Clinical Trial Associate remotely.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 realize their potential through life-changing
work. Certified as a Global Top Employer, we offer stimulating
careers, encourage innovation, and strive for 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 a vital contributor to our inspiring, bold
mission.OBJECTIVESThe remote-based Senior Clinical Trial Associate
(CTA) will independently perform tasks related to supporting
operational strategy, planning, and execution of clinical studies,
supporting the strategy as defined in the Clinical Development
- Provide support for critical day-to-day clinical study
activities, including inspection readiness and/or oversight of
inspection deliverables and/or milestones, in accordance with
established protocols under the general supervision of the CTA
- Collaborate with Clinical Operations Manager, study teams, and
Clinical Research Organizations (CROs) to support clinical study
activities as defined by the clinical trial operating model.
- Perform departmental tasks as needed, including acting as a
subject matter expert or oversee initiatives and/or processes; act
as mentor to junior CTA team members.
- Perform developmental tasks as appropriate with oversight of
CTA Manager.ACCOUNTABILITIES:For assigned complex, accelerated,
and/or business critical studies, provide support to focus on study
start-up and site initiation activities, including but not limited
- Review and/or approval of study documentation, including
essential document packets, study plans, informed consent forms,
- Supporting oversight of risk-based monitoring.
- Attendance of key team meetings as required; may make
presentations (e.g. data, resourcing, initiatives, etc.).
- Supporting regulatory inspection readiness (e.g. preparation of
materials and/or participation and/or oversight of deliverables and
milestones during regulatory inspections.)
- Supporting additional ad-hoc activities as needed, as agreed
with CTA Manager.For all assigned studies, provide support
- Collaboration with internal departments (Legal, Insurance,
R&D functions, etc.), CROs, and external vendors.
- Escalation of clinical trial insurance issues.
- Supporting Health Care Provider Engagement for facilitating
contracts and meetings.
- Supporting vendor contract administration as required.Provide
support for departmental tasks, including but not limited to:
- Maintaining knowledge and acts as team super-user or subject
matter expert for related systems and processes; provide
presentations, training, and support to CTA team as needed; provide
updates to applicable CTA resources as needed.
- Participating in and/or leading functional initiatives and/or
- Assisting with special projects and/or tasks as required.
- Acting as mentor to junior CTA team members.
- Supporting new CTA team member onboarding.Perform developmental
tasks as appropriate with oversight of CTA Manager, including:
- Career development and goal setting.
- Targeted skill development and/or growth of knowledge
base.DIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise
- Provide expertise in start-up activities and operating model to
- Understanding and application of GCP, ICH, and applicable
regulatory standards governing clinical research.
- Comfortable with technology and able to learn new systems
- Strong knowledge of MS Word, Excel, PowerPoint, and
- Managing deliverables; demonstrating the ability to lead others
to drive deliverables forward.
- Navigation of changing priorities and communication about
changes.Decision-making and Autonomy
- Ability to work in a fast-paced environment with demonstrated
ability to manage multiple competing tasks and demands.
- Ability to work with timelines and complete tasks according to
- Problem solving study-related issues; demonstrating
resourcefulness and independence; escalation of issues as
- Must be able to professionally interact and communicate with
internal departments (Legal, Insurance, R&D functions, etc.),
CROs, and external vendors.
- Ability to effectively collaborate with both internal and
external study team.
- Ability to work in a matrix environment.
- Coordination with external vendors as needed.Innovation
- Knowledge sharing with study teams as needed.
- Working with process owner for optimization of the
- Knowledge sharing with the CTA team as needed.Complexity
- Requires strong attention to detail in composing and/or
proofreading and/or approving study materials, establishing
priorities, scheduling, and meeting deadlines.
- Ability to take ownership and manage tasks, as well as
- Assigned clinical studies may be high complexity and/or high
- More than one study and/or more than one program may be
- Interactions with study teams and other colleagues are both
local and remote (in varying locations and timezones).EDUCATION,
BEHAVIOURAL COMPETENCIES AND SKILLS:EducationBachelors degree or
equivalent international degree required.Experience
- 3-5 years experience in pharmaceutical industry, clinical
research organization, or related role.
- Experience in Phase 2 and 3 studies and global/international
studies is advantageous.
- Experience working across multiple therapeutic areas (including
oncology) is advantageous.Skills
- Knowledge in global regulatory and compliance requirements for
- Demonstrated excellence in task management and cross-functional
- Excellent leadership skills.
- Excellent communication skills.
- Excellent teamwork, organizational, interpersonal, and
- Fluent business English (oral and written).TRAVEL
REQUIREMENTS:Requires availability for 5-10% domestic and/or
international travel, including overnight and international travel
on an as-needed basis.WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- 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: $60K-85K based on candidate professional
experience level. Employee may also be eligible for Short Term
and/or Long Term incentive benefits. Employees are eligible to
participate in Medical, Dental. Vision, Life Insurance, 401(k),
Charitable Contribution Match, Company Holidays, Personal &
Vacation Days, Student Loan Repayment Program and Paid Volunteer
- If candidate is not eligible for any benefits or other comp.,
those can be excludedThis posting is made in compliance with
Colorados 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 Please.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, Columbus , Senior Clinical Trial Associate/Lead Clinical Trial Associate, Healthcare , Columbus, Ohio
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