Associate Director Clinical Data Standards
- R+D/ Global Development Support
- Reports to Director, Clinical Data Solutions
- Boston, MA
- $140,000 - 200,000 +complete benefits package
- A Pharmaceutical company is looking to hire for an Associate Director Data Standards position. This position is accountable for managing and organizing the development, deployment, management and governance of clinical standards required to sustain drug development processes as well as supporting standards proposals and CROs/strategic service supplier interactions. Additionally, responsible as an individual contributor role that entails project management leadership of standards projects and the capability to partner closely with internal/external standards stakeholders in a collaborative manner.
The AD Data Standards position will have responsibilities that include:
- Leadership role in standards project implementation.
- Plays as Standards area development manager for designated standards projects.
- Determines and supports development plans and effectively articulates them; defines risks and recommends contingency plans.
- Possesses, governs and maintains designated GDO developed standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, ADaM, TFLs and questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts.
- Guarantees CROs/strategic service providers and this pharmaceutical company are deploying standards and leveraging them across the organization at an enterprise level.
- Conducts assessment, implementation, integration and governance of systems and tools to support, manage, govern and report on standards.
- Organizes standards compliance review and works with operational areas and CROs/strategic service providers to reinforce content and interpretation of pharmaceutical company's standards.
- Delivers to budget forecasting and resourcing requirements.
- Reviews proposals and participate in the selection of service/technology providers.
- Manages contracts and statements of work.
- Cooperates diligently with CROs/Strategic service providers to ensure appropriate management, training and deployment of Takeda's standards within the service provider's infrastructure.
- Exemplifies company's and Global Development Operations as a member of Standards Development Organization or Standard Support Groups (e.g. CDISC, PhUSE).
- Leads a Standards Area Working Group/Team.
The ideal candidate will have the following skill set:
- B.S. degree in Scientific or related field is preferred.
- Minimum 8-10 years in Data Standards or Data Management or Programming or Statistics.
- Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology.
- Knowledge of XML preferred.
- Experience with leading teams and/or organizations. Demonstrated knowledge of drug development process.
- Demonstrated knowledge of regulatory guidances, requirements and industry standard practices as pertaining to clinical data standards and metadata management.
- Strong attention to detail and accuracy is a must.
- Ability to read, analyze and interpret complex technical documents and to present complex issues in oral and written form. · Ability to think strategically and to develop new approaches and processes.
- Ability to facilitate discussions and share knowledge across multiple study teams, functional lines and management levels.
- Ability to work independently, take initiative and complete tasks to deadlines.
- Knowledge of at least one data management system and/or working knowledge of SAS.
- Must have an understanding of database concepts.