- Entry level
- No Education
- Salary to negotiate
Dir Clinical Data Solutions
Reports To (Title):
Vice President, Global Clinical Data Management & Technology
Global Development Support
Clinical Data Management & Technology
- Responsible for ensuring timeliness and high quality for all Data Management (DM) deliverables globally within a key therapeutic area. Provides oversight of DM budget in collaboration with program management.
- Provides data management expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.
- Responsible for oversight of data management strategic vendor partnerships in order to maximize effectiveness and efficiency of external (CRO) resources.
- Benchmarks industry best practices and changes in Data Management process, outsourcing strategies and DM vendor management. ACCOUNTABILITIES:
- Responsible for all vendor oversight activities across all global development programs within a key therapeutic area for Takeda. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Sets strategy and leads functional governance with Takeda’s strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics:Design and implementation of data capture toolsData processing, coding and validationResponsible for the quality of the data in each database, as well as quality of other data management deliverables
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
- Responsible for forecasting future outsourcing needs, assessing vendor capacity against assigned work and aligning vendor strategy with these factors.
- Oversees the planning and management of external Data Management budgets (in collaboration with Clinical Operations TA Leads) to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
- Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
- Identifies, recommends and drives changes in industry best practices and/or regulatory trends
- Other duties as assigned Required EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:
- BS degree in analytical or health-related field (MS preferred).
- 10+ years of data management experience in the pharmaceutical industry
- Expert knowledge and successful experience managing vendor relationships and alliance partnerships with at least 7 years experience in this area
- 5+ years of line management experience (prior second-level management experience preferred).
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Experience with budget planning
- Strong knowledge of relational databases and experience using multiple clinical data management systems
- Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
- Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function. Locations
Job ID R0017880
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