Sr Clinical Trials Associate (CTA) Manager
Company: Takeda Pharmaceuticals
Posted on: September 22, 2022
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to the best of my knowledge.Job DescriptionOBJECTIVES/PURPOSE :The
CTA Manager is responsible for management of assigned Clinical
Trial Associates (CTAs) ensuring optimal use of resources and
skillsets to deliver effective clinical trial support. The CTA
Manager will be responsible for direct line management, ensuring
appropriate training and oversight to ensure consistent and
high-quality trial support across programs.In collaboration with
CTA Management team and Clinical Operations Lead(s), ensures
resources are aligned to resourcing strategies and business
critical goals and milestones.The CTA Managers acts as subject
matter expert to support complex activities such as process
development, complex program support or department and/or business
critical initiatives and deliverables.A CCOUNTABILITIES:In
collaboration with Head of Clinical Document Management and Trial
Support and/or Clinical Operations Program Leads to ensure CTA
resources are aligned with business-critical activities.
Contributes to departmental long-range resource forecasting and
strategies. Partners with other CTA Managers to optimize on
resource and skillsets for effective allocation of resources that
are appropriate to their experience and development
goals.Contributes to development of and leads assigned departmental
objectives and business goals, representing CTA Management and
GDO.Leads and/or serves as subject matter expert in complex
activities such as trial process development, complex therapeutic
area and/or program support or department and/or business critical
initiatives and deliverables.Promotes a positive, results-driven
environment which models teamwork and provides visibility into
successes.Manages day to day activities of the assigned staff
providing guidance, coaching and supporting issue escalation.
- Motivates the team to achieve organizational goals, delegating
tasks and implementing timelines to achieve targets to ensure high
quality service and outstanding stakeholder support.
- Ensures all employees receive appropriate training and
- Empowers team members with skills to support development growth
and subject matter expertise.
- Supports team to successfully achieve individual business and
development goals supporting issues and providing guidance on a
- Provides informal feedback on an ongoing basis and formally in
the annual performance evaluation process to support continued
- Contributes to staffing for CDMTS through the appropriate
hiring, performance management and succession planning.CORE
ELEMENTS RELATED TO THIS ROLE:The CTA Manager is responsible for
managing a team of assigned Clinical Trial Associates (CTAs) of
increasing level of experience to deliver effective clinical trial
support across a large portfolio of active critical trials and
therapeutic areas. The CTA Manager will be responsible for direct
line management, ensuring appropriate training and oversight to
ensure consistent and high-quality trial support across programs
which are aligned to resourcing strategies and business critical
goals and milestones.As a subject matter expert, the CTA Manager
will support complex activities such as process development,
complex program support or department and/or business critical
initiatives and deliverables.DIMENSIONS AND
ASPECTS:Technical/Functional (Line) Expertise
- Current awareness, understanding and application of ICH GCP and
applicable regulatory standards governing clinical research. along
with a general understanding of the drug development process.
- Comfortable with technology and able to learn new systems
- Strong knowledge of Microsoft applications.Leadership
- Ability to communicate and influence stakeholders
- Managing deliverables; demonstrating the ability to lead others
to drive deliverables forward.
- Navigation of changing priorities and communication about
- Leads team in manner which motivates, provides stretch goals
and supports a culture of continued personal growth and development
within Takeda.Decision-making and Autonomy
- Ability to work in a fast-paced environment with demonstrated
ability to manage multiple competing tasks and demands.
- Problem solving study-related issues; demonstrating
resourcefulness and independence; escalation of issues as
- Must be able to professionally interact and communicate with
internal departments at all levels of the organization internally
and with external vendors.Innovation
- Actively identifies continuous improvement opportunities to
enhance operational efficiencies through process and metrics
analysis and audit outcomes.
- Participates in workstreams which contribute to the
development, implementation and successful adoption of R&D
systems and processes.Complexity
- Overseeingresources to support a large cross-therapeutic
- Optimizing the resources and skill sets of a teamto deliver
targets and work in a cross functional setting on trial
- Interactions with cross functional teams and business units
including Senior program or function management.
- Composing and approving process documentation, establishing
priorities, scheduling, and meeting deadlines.
- Ability to take ownership and manage tasks, as well as
- Working on multiple assigned projectswhich may be complex
and/or high risk.EDUCATION, BEHAVIOURAL COMPETENCIES AND
- Bachelors degree or equivalent preferred*Experience:*
- Minimum 5 years+ experience in pharma industry, CRO, or related
- Familiarwith requirements for clinical trials (ICH/GCP)and
- Prior experience in line management preferred and/or experience
as a mentor/supervisor to staff members.Skills:
- Abilityto manage a team to meet company objectives.
- Experience mentoring or supervising other members of staff in
some capacity, direct line management preferred.
- Ability to work independently, take initiative, establish
priorities, complete tasks to deadlines.
- Strong communication skills and customer focus with ability to
interact in a global, cross-functional organization.
- Proven ability to communicate effectively andrespond to
inquiries and concerns, support issue escalationand propose
mitigation strategies where feasible.
- Must be able to work in a fast-paced environment with
demonstrated ability to prioritize multiple competing tasks and
- Advanced computer proficiency
- Demonstrated ability to be flexible and to adapt quickly to
- Excellent teamwork, organizational, interpersonal, and problem
- Fluent business English (oral and written).ADDITIONAL
- Full driving license and passport required
- May be required to attend on-site (Lexington and/or Cambridge,
MA USA) to support business critical activities on an as-needed
basis if remote-based
- 10% domestic and/or international travel, including overnight
and international travel on an as-needed basis
- In accordance with the CO Equal Pay Act, Colorado Applicants
Are Not Permitted to Apply.
- Base Salary Range $130,200 - $186,000 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
- This position is currently classified as remote in accordance
with Takedas Hybrid and Remote Work policy.This posting is made in
compliance with Colorados 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
Keywords: Takeda Pharmaceuticals, Providence , Sr Clinical Trials Associate (CTA) Manager, Healthcare , Providence, Rhode Island
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