Director, Clinical Data Management Medical Coding

Takeda • MA

135d • $174,500 - $274,230

About The Position

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.

Requirements

• 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.
• Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum.
• 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.

Responsibilities

• Responsible for designing and implementing the medical coding strategy for Takeda clinical trial data, including staffing model and vendor partnership strategy.
• 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.
• Responsible for oversight conduct of Data Management Coding activities at the program, group of programs and/or portfolio level.
• Provide and enable solutions for complex problem solving that align with the Takeda values.
• 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.
• Lead the design and implementation of Takeda’s long-term clinical trial data coding strategy.
• Ensure achievement of clinical trial coding deliverables and activities that support Takeda regulatory commitments.
• 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.
• Develop, implement, and evaluate Takeda coding conventions to ensure consistency and to optimize integration capabilities.
• Develop and maintain strong relationships with vendors who perform clinical trial coding.
• 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.

Benefits

• Base Salary Range: $174,500.00 - $274,230.00
• Eligible for short-term and/or long-term incentives.
• Eligible to participate in medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Eligible to receive up to 80 hours of sick time per calendar year.
• New hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees