Associate Director, Business Operations DMC Lead

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Associate Director, Business Operations DMC Lead based in Cambridge, reporting to the Executive Director, GDO Business Operations.

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 work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Provide end to end centralized end user/customer support for specified functional areas within Global Development Organization (GDO) & study teams when engaging an HCP to ensure compliance with Takeda transparency and external reporting requirements.
• Responsible for leading operational, project management and coordination for the Data Monitoring Committee(s) / Internal Review Committee(s) (DMC/IRC) activities. Key point of contact for DMC members and DMC Sub-Team members.
• Deliver educational training on centralized HCP engagement process and participate in the development of training materials/job aids.
• Identify supplier(s) of choice for DMC execution and oversee day to day management of vendor(s).
• Serve as a key point of contact for specified functional areas within GDO for HCP engagements including consulting with key stakeholders (e.g., Global/Local Compliance, Legal, Meeting Vendors, CRO partners etc.) on behalf of the function.
• Develop, implement, and maintain DMC/IRC R&D wide communication strategy.
• Partner with Global Clinical Development Operations Process Excellence and Delivery team  to determine key performance indicators and measurement of DMC/IRC performance and provide recommendations for areas for improvement.

ACCOUNTABILITIES:

• Collaborate with DMC/IRC Leads in Clin Sci & / or PSPV to finalize DMC timeline, meeting cadences and meeting formats.
• Coordinate the authoring of the DMC/IRC Charter, by partnering with functional representatives, and review with Takeda DMC Lead and DMC Chairperson to finalize version. 
• Distribute and retrieve disclosure forms and contracts, for HCP engagement.
• Prepare and process contract requests, accruals, transparency reporting and correspondence with Health Care Practitioners for GDO. Request/confirm payments to external members per the contract.
• Ensures project management support of the DMC/IRC and continuously improves DMC/IRC processes and structure leveraging technologies to expedite escalation, decision making, and communication related to DMC/IRC activities.
  • Coordinate initial and subsequent meetings per the charter.
  • Distribute charter and any updates to DMC/IRC, collect signatures, and archive in TMF.
  • Prepare meeting minutes, distribute draft, finalize, and archive.
  • Distribute/ensure receipt of data to all DMC/IRC members prior to meetings; coordinate data receipt as prepared by independent statistician per charter.
  • Close-out all HCP engagement/meetings in relevant Takeda systems; Complete targeted reconciliation of engagement.

• Partner with R&D Compliance to support year-end close-out activities in preparation for transparency reportin