Head Clinical Data Solutions
- R+D/ Global Development Operations
- Boston, MA
- $200,000 - 280,000 +complete benefits package
- A Pharmaceutical company is looking to hire for a Head Clinical Data Solutions position. This position develops, employs and supervises an operational data proprietorship scheme in support of global development strategies and promoted products for all of this company's therapeutic areas. Additionally, drives strategy to guarantee conformity to CDISC standards for all enhancement programs and promoted products to ensure regulatory submission fulfilment.
The Head of Clinical Data Solutions will have responsibilities that include:
- Data collection/extraction approach and affiliation with clinical protocol / industry data standards. Incorporating oversight of CRO-led implementation, execution and distribution of clinical data
- Lead and coordinate the Global Development Operations technology systems policy, in collaboration with desired vendors, therapeutic area units and IT, to support the timely and efficient delivery of global development programs with high quality and within allotted budget.
- Expands, implements and supervises an functioning data ownership strategy in support of global development projects and marketed products for all Takeda therapeutic areas.
- Drives strategy to ensure compliance to CDISC standards for all development programs and marketed products to ensure regulatory submission compliance.
- Present understanding on latest technologies and changes in governing environments, enabling practical approach and planning to meet future obligations and efficient study and data management support of global development programs.
The ideal candidate will have the following skill set:
- BS degree in Computer Science, Life Science or other technical field required; advanced degree desired.
- 10+ years of applicable informatics, systems and /or relevant drug development experience; global experience and experience in drug development strongly preferred.
- 8+ years of project management and leadership experience
- Experience of general database programming and computing principles, common software products and technologies used in drug development
- Ability to develop and evaluate business cases and effectively manage budgets
- Excellent understanding of FDA and ICH regulations and industry standards applicable to drug development systems