Director, Clinical Data Management Medical Coding

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 for Takeda in collaboration with key stakeholders.

• Ensure review of program and study level clinical trial adverse events, serious adverse events (SAE), concomitant medications and other relevant coded data performed by vendors for quality and consistency.

• Develop and manage coding staff to support Takeda’s medical coding strategy.

• Participate in and provide strategic input to cross-functional initiatives such as cross-functional data review, study operational initiatives, and technology initiatives.

EDUCATION AND EXPERIENCE:

• MS/BS degree (RN or RPH preferred) in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience

• 10 or more years of clinical data management coding experience in the pharmaceutical or biotechnology industry.

• 7 or more years experience of expert knowledge managing vendor relationships and alliance partnerships.

• 5 or more years of line management experience or equivalent.

• Proven track record of strong project management skills and experience managing data management coding activities for large drug development programs.

• Expert knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management and medical coding; clinical experience in the one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, and/or vaccine.

• Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post-marketing safety data management). 

• Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

• Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

• Strong understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

• Strong knowledge of one or more coding and clinical trial data management systems (Oracle Clinical, Oracle TMS, Medidata RAVE, InForm, etc.). 

• Experience overseeing vendors performing clinical trial medical coding. 

• Experience developing and maintaining coding processes and conventions.

• Experience liaising with senior-level stakeholders.

• Experience with budget planning. 

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.