14 days old

Study Operations Specialist

Millennium Pharmaceuticals, Inc.
Cambridge, MA 02139
  • Job Code
    R0037325

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Study Operations Specialist in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Study Operations Specialist working on the Clinical Development Services team, you will be empowered to provide end to end customer support for HCPs and support inspection readiness and TMF activities, and a typical day will include:

POSITION OBJECTIVES:

  • Provide end to end centralized end user/customer support for specified functional areas within Research & Development (R&D) when engaging an HCP to ensure compliance with Takeda transparency and external reporting requirements
  • Lead and participate in business process development and improvement activities
  • Deliver educational training on centralized HCP engagement process and participate in the development of training materials/job aids
  • Serve as a key point of contact for specified functional areas within R&D for HCP engagements including liaising with key stakeholders (e.g., Global/Local Compliance, Legal, Meeting Vendors, CRO partners etc.) on behalf of the function

POSITION ACCOUNTABILITIES:

HCP Engagements:

  • Provide end to end centralized customer support for HCP engagements within specified functional areas within R&D including:
  • Liaise with key stakeholders (e.g., HCP Requestor, Legal, Compliance, etc) to obtain the required approvals (e.g., venue, travel, accommodation etc.) prior to engaging the HCP
  • Work with Legal and HCP requestor to ensure fully executed HCP agreements are in place prior to the engagement
  • Partner with meeting planning vendors to ensure HCP meeting/engagement information, document and financial information is entered into relevant Takeda systems
  • Close-out all HCP engagement/meetings in relevant Takeda systems; Complete targeted reconciliation of engagement
  • Work closely with R&D Compliance to support year-end close-out activities in preparation for transparency reporting deadlines
  • Contribute to the development/maintenance of HCP Engagement Leadership Oversight Dashboard
  • Participate in regular R&D Compliance monitoring activities including the responses and implementation of action plans (as required)
  • Participate in relevant projects, meetings and transparency reporting activities (as needed)

Other Clinical Services Activities:

  • Support overall inspection readiness and TMF activities, as needed
  • Assist in documentation management and operational data activities
  • Support SOP revisions and process documentation updates, as needed

EDUCATION, EXPERIENCE AND SKILLS:

  • High school diploma or GED required. Associates degree preferred.
  • Minimum 5 years of project administration and/or administrative experience. Strong PC literacy with intermediate skills in Microsoft Outlook, Word, Excel or PowerPoint. Excellent verbal and written communication skills
  • Advanced organizational and communication skills
  • Demonstrated negotiation and persuasion skills
  • Excellent customer service skills/techniques
  • Demonstrated ability to handle multiple tasks simultaneously and adjust to changing priorities
  • Clear oral and written communication skills on complex topics
  • Ability to identify more complex issues that require escalation for resolution
  • Fully understand importance of data integrity and attention to detail
  • Have experience working with complex databases and ensuring accurate data entry
  • Enthusiasm for innovative research and ability and desire to learn new approaches, technologies and expand core skill set.

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-PW1

This posting excludes CO applicants

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Study Operations Specialist

Millennium Pharmaceuticals, Inc.
Cambridge, MA 02139

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