Clinical Trial Associate Manager
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Clinical Trial Associate Manager in Lexington.
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.
The Clinical Trial Associate Manager works independently to manage study start- up activities for key identified clinical studies in conjunction with the aligned clinical programs managers. In addition, the CTA Manager is responsible for direct line management of the Clinical Trial Associates (CTA) within their assigned studies. The CTA Manager will be responsible for assigning resources to achieve study team goals and objectives and ensuring appropriate training of assigned CTAs in .order to deliver operational consistency and support across the program to support the operational teams.
Line Management Activities:
- Under supervision of the Head of Clinical Study Support, manage staff in accordance with organization's policies and applicable regulations. Responsibilities include hiring FTEs and contractors, planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.
- Liaise with Head of Clinical Study Support and/or Global Clinical Operations Leads to ensure allocation of CTA staff are aligned with department priorities.
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies/programs that are appropriate to their experience and training.
- Identify and ensure all necessary training is provided to CTAs on an ongoing basis to optimize job performance and knowledge of Shire procedures, ICH-GCP and other local regulations.
- Demonstrate leadership to direct reports, ensuring employees adhere to corporate policies and following up with management as appropriate.
- Monitor and evaluate assigned CTA workloads ensuring timely completion of project deliverables as requested by the Clinical Program Managers.
- Ensure compliance with pre-defined roles and responsibilities matrix for the management of CTAs.
- Serve as an ongoing liaison with the relevant clinical study teams, and provide feedback regarding corporate goals and objectives as well as performance of direct reports.
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the teams and stakeholders in an open, balanced and objective manner.
Key Clinical Study Support:
- Directly support Clinical Program Manager(s) with regards to day to day activities for key clinical studies.
Study Start-Up Activities:
- Lead Clinical Operational Excellence & Support service Plan meetings and assists the study team(s) to ensure CRO Scope of Work is in alignment with the study oversight necessity.
- Provides clinical study start up expertise and ensures identified efficiencies within study start-up are implemented.
- Assists in providing oversight of CRO for site identification and selection activities
- Provides oversight of Clinical CRO activities regarding Legal review/negotiation/execution of confidentiality and site agreements.
- Provides oversight of Clinical CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.
- Ensures effective communication between Shire and the Clinical CRO.
- Provides oversight of Essential Documents for lnvestigational Medicine Release as per relevant SOP.
- Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
- Assists and/or participates in planning and conduct of Investigator's Meetings as necessary.
Study Maintenance & Close out Activities (as Necessary):
- Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.
- Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
- Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
- Assists study team with preparation for audits/inspections
- Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.
- Liaises with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly.
Departmental and Process Related Tasks:
- Maintains knowledge and acts as team super user or subject matter expert for Shire systems and processes.
- Support department wide process training and awareness initiatives
- Participates in inter-departmental workgroups to create or enhance processes
- Maintains up to date training record attending internal/external training(s) as necessary.
Education and Experience Requirements
- Bachelor's degree required (Advanced degree or certification preferred but not required)
- Minimum 5 year's experience in relevant role (eg. Sponsor, CRO or Clinical Study Vendor)
- Prior experience in line management and/or experience as a mentor/coach to staff members
Other Job Requirements
- Minimal travel may be required
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 Programs
Empowering Our People to Shine
Discover more at takedajobs.com
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.