Takeda is looking for a Director, Clinical Data Management Medical Coding to design and implement the medical coding strategy for their clinical trial data, ensuring timely and quality coding deliverables that meet industry and regulatory requirements. This role will oversee staff, vendors, and processes to ensure compliance and efficiency in coding activities across global development programs.
Requirements
- 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).
- Expert knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management and medical coding
- Strong knowledge of one or more coding and clinical trial data management systems (Oracle Clinical, Oracle TMS, Medidata RAVE, InForm, etc.).
- Experience developing and maintaining coding processes and conventions.
- Experience overseeing vendors performing clinical trial medical coding.
- 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.
Responsibilities
- Responsible for designing and implementing the medical coding strategy for Takeda clinical trial data, including staffing model and vendor partnership strategy.
- Manage and oversee Takeda staff, strategic partners and vendors who conduct coding activities.
- Provide and enable solutions for complex problem solving that align with the Takeda values.
- 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.
- 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.
Other
- 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.
- Experience liaising with senior-level stakeholders.
- Experience with budget planning.
