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Takeda Pharmaceuticals Sr Clinical Trials Associate (CTA) Manager in Helena, Montana

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Job Description

OBJECTIVES/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 education.

  • 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 day-to-day basis.

  • Provides informal feedback on an ongoing basis and formally in the annual performance evaluation process to support continued development growth.

  • 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 quickly.

  • 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 changes.

  • 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 needed.

Interaction

  • 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 portfolio.

  • Optimizing the resources and skill sets of a teamto deliver targets and work in a cross functional setting on trial execution

  • 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 communicate effectively.

  • Working on multiple assigned projectswhich may be complex and/or high risk.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s degree or equivalent preferred 

*Experience: *

  • Minimum 5 years+ experience in pharma industry, CRO, or related role. 

  • Familiarwith requirements for clinical trials (ICH/GCP)and regulatory submissions.

  • 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 demands

  • Advanced computer proficiency

  • Demonstrated ability to be flexible and to adapt quickly to change

  • Excellent teamwork, organizational, interpersonal, and problem solving skills.

  • Fluent business English (oral and written).

ADDITIONAL INFORMATION:

  • 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 Off.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.

EEO Statement

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.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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