Lead Clinical Trial Associate
Company: Takeda Pharmaceuticals
Posted on: November 27, 2022
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to the best of my knowledge.Job DescriptionLead 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 Lead 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 Plan.
- Provide support for critical day-to-day clinical study
activities, in accordance with establishedprotocols under the
general supervision of the CTA Manager.
- Provideoversight of deliverables and milestones and/or lead CTA
team duringregulatoryinspections and/or develop strategies for
- Collaborate with Clinical Operations Manager, study teams, and
Clinical ResearchOrganizations (CROs) to support clinical study
activities asdefined by the clinical trial operating model.
- Provide leadership to the CTA team and study teams for more
- Performdepartmental tasks asneeded, includingactingas a
subjectmatterexpert or lead initiatives and/or processes; make
presentations to Clinical Operations; act asmentor to junior CTA
- Performdevelopmental 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
- May support more complexprograms and studies to define and
execute best clinical trial support strategies.
- Review and/or approval of study documentation,
includingessentialdocumentpackets, study plans,
- Supportingoversight of risk-based monitoring.
- Attendance of key team meetings asrequired; may make
presentations (e.g. data, resourcing, initiatives, etc.).
- May make presentations to senior leadership of therapeuticareas
and/or R&D functionalareas.
- Supportingregulatoryinspectionreadiness (e.g. preparation of
materials and/or participationand/or oversee deliverables and
milestones and/or lead CTA team duringregulatoryinspections and/or
develop strategies for regulatoryinspections.)
- Supportingadditional ad-hoc activities asneeded, asagreed with
CTA Manager.For all assigned studies, provide support including:
- 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.
- May make presentations to Clinical Operations.
- Participating in and/or leading and/or initiating functional
initiatives and/or working groups.
- 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 (
Breadth and depth of knowledge, application and complexity of
technical knowledge )
- Provide expertise in complexstart-up activities and operating
model to study teams.
- Understanding and application of GCP, ICH, and
applicableregulatory standards governing clinical research.
- Comfortable with technology and able to learn new systems
- Strong knowledge of MS Word, Excel, PowerPoint, and
Outlook.Leadership (Vision, strategy and business alignment, people
management, communication, influencing others, managing change)
- Managing deliverables; demonstrating the ability to lead
othersto drive deliverables forward.
- Lead and/or supervisecomplex projects.
- Navigation of changingpriorities and
communicationaboutchanges.Decision-making and Autonomy ( The
capacity and authority to make organizational decisions , autonomy
in decision-making, complexity of decisions, impact of decisions,
problem- solving )
- Ability to work in a fast-pacedenvironment with
demonstratedability to manage multiple competing tasks and
- Ability to work with timelines and complete tasks according to
- Problem solving study-relatedissues;
demonstratingresourcefulness, independence, and leadership;
escalation of issuesasneeded.Interaction (The span and nature of
ones engagement with others when performing ones job , internal and
external relationships )
- Must be able to professionallyinteract and communicate with
internaldepartments (Legal, Insurance, R&D functions, etc.),
CROs, externalvendors, and senior leadership of therapeuticareas
and R&D functions).
- Ability to effectively collaborate with bothinternal and
external study team.
- Ability to work in amatrixenvironment.
- Coordination with externalvendorsasneeded.Innovation (The
required level of scientific knowledge, knowledge sharing,
innovation and risk taking )
- Knowledge sharing with study teams asneeded.
- Working with processowner for optimization of the process.
- Knowledge sharing with the CTA team asneeded.Complexity ( P
roducts managed, mix of businesses, internal and/or external
business environment , cultural considerations )
- Requires strong attention to detail in composing and/or
proofreading and/or approving study materials,
establishingpriorities, scheduling, and meeting deadlines.
- Ability to take ownership and manage tasks,
- Assigned clinical studies may be high complexity and/or high
- More than one study and/or more than one programmay be
- Interactions with study teams and othercolleagues are bothlocal
and remote (in varying locations and timezones).EDUCATION,
BEHAVIOURAL COMPETENCIES AND SKILLS:Education
- Bachelors degree or equivalent international degree required
- 4-5years experience in
- Experience in Phase 2 and 3 studies and global/international
- Experience working acrossmultipletherapeuticareas
- Knowledge in global regulatory and compliance requirements for
- Demonstratedexcellence in task managementand
- Excellent leadership skills.
- Excellentcommunication skills.
- Excellentteamwork, 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: is 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, Topeka , Lead Clinical Trial Associate, Healthcare , Topeka, Kansas
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