Associate Director, Clinical Data Standards
Takeda
- Cambridge, MA
- Permanent
- Full-time
- Provides input to clinical data standards governance with Takeda’s strategic stakeholders.
- Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
- Participates and represents function in formal inspections and audits as requested.
- Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.
- Represents function in external professional initiatives and organizations such as CDISC, PhUSE, SCDM, SCOPE, PharmaSUG, TransCelerate, Accumulus, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
- Partners with internal stakeholders, clinical operations, CDM, and external CROs and provide guidance on data harmonization across diverse sources.
- Leads process and workflow improvement in areas of Standards implementation from Sample Collection through Data Transfer.
- Defines and/or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
- Ensures compliance with own Learning Curricula, corporate and/or GXP requirements.
- Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data deliverables.
- Contributes to the development of strategies and governance for assessing, implementing, and integrating systems and tools to support, manage, govern and report on data standards.
- Responsible for the maintenance of structure and content of Takeda's MDR - Metadata Repository in one or more of the areas: data transfer specifications, eCRF and other data collection methods e.g., eSource, ePRO, forms, controlled terminologies, instructions, edit checks, SDTM mappings, ADaM and TLF standard libraries.
- Leads and enforces maintenance and decommissioning of Clinical Data Standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, ADaM, TLFs and questionnaires). Includes regular assessment of standards content with respect to compliance and industry impacts. May prepare metrics to support the function’s KPIs.
- BS/BA or MS in a life science or analytical area with minimum 10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
- Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus.
- Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs