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Clinical Trial Associate Manager

Lexington, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Self-starter
  • Versatile
  • Team player

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Opportunity

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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Clinical Trial Associate Manager

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Job ID SR0041947 Date posted 09/26/2019 Location Lexington, Massachusetts

Primary Duties

The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s). The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager.The CRA performs work within established protocols under general supervision.

Responsibilities

85% - Clinical Trial Support (May include but not limited to activities listed)

Study Start-Up Activities:

  • Assists the study team(s) to deliver the clinical study within agreed timelines.
  • Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors.  (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
  • Provides oversight of Clinical CRO Investigator background checks.
  • Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.
  • Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
  • Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
  • Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
  • Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System.
  • Assists and/or participates in planning and conduct of Investigator’s Meetings as necessary.

Study Maintenance Activities:

  • 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.
  • Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.

Study Close Out Activities:

  • 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.

10% Departmental Tasks:

  • Maintains knowledge and act as team super user or subject matter expert for related systems and processes. 
  • Maintains up to date training record attending internal/external training(s) as necessary.
  • Participates in inter-departmental workgroups to create or enhance processes.

5% -  Development Tasks

Development tasks may be assigned to a CRA as appropriate upon discussions with manger:

  • Assist in providing oversight of CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.

Education and Experience Requirements

  • Bachelor's degree required           
  • 3-5 year's experience in similar/relevant field (eg. Sponsor, CRO, Clinical trial Vendor, Clinical Coordinator, etc.)
  • People management experience preferred

Other Job Requirements

  • Available for up to 10% domestic and/or international travel

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.

Job ID SR0041947

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