Director, Clinical Data Management Medical Coding

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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 Director, Clinical Data Management Medical Coding based remotely reporting to the VP, Clinical Data Operations & Standards.

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:

• Responsible for designing and implementing the medical coding strategy for Takeda clinical trial data, including staffing model and vendor partnership strategy. They will ensure delivery of timely and quality coding deliverables for clinical trials and programs in order to meet industry and regulatory requirements for clinical trial coding.

• Manage and oversee Takeda staff, strategic partners and vendors who conduct coding activities. They are responsible for oversight conduct of Data Management Coding activities at the program, group of programs and/or portfolio level - as performed within Takeda or by strategic partners, CROs or other 3rd party vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.

• Provide and enable solutions for complex problem solving that align with the Takeda values. They will liaise with Takeda pharmacovigilance and medical leaders to ensure alignment across functional areas and stakeholder groups on the medical coding strategy, implementation, and quality oversight.

• Provide coding expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.

ACCOUNTABILITIES:

• Lead the design and implementation of Takeda’s long-term clinical trial data coding strategy, including staffing model, vendor partnership, technology selection and adoption as applicable.

• Ensure achievement of clinical trial coding deliverables and activities that support Takeda regulatory commitments including submission of safety data.

• Liaise with cross functional and technology senior leaders to ensure alignment on medical coding strategy.

• Serve as a medical coding subject matter expert.

• Partner with stakeholders to optimize technology that supports efficient dictionary management processes and oversight of vendor coding quality. 

• In collaboration with Takeda’s Global Coding Committee develop, implement, and evaluate Takeda coding conventions to ensure consistency and to optimize integration capabilities within and across therapeutic areas and programs. 

• Develop and maintain strong relationships with vendors who perform clinical trial coding, ensuring high quality deliverables, consistent application of coding conventions, implementation, and oversight of metrics to ensure quality and productivity, appropriate resourcing, and process improvements as necessary. 

• Develop and maintain coding and dictionary management process fo