Associate Director, Clinical Data Solutions- Early Oncology

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Job Description Job Title: Associate Director Clinical Data Solutions
– Early Oncology OBJECTIVES (optional): Responsible for ensuring timeliness and high quality for all Data Management (DM) deliverables globally within a 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.

Contributes to management of strategic vendor partnerships in order to maximize effectiveness and efficiency of external (CRO) resources.

ACCOUNTABILITIES: Responsible for vendor oversight activities across all global development programs within a therapeutic area.

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.

Provides input to 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 tools Data processing, coding and validation Responsible 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 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.

Other duties as assigned Required EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS: BS degree in analytical or health-related field.

10 years of data management experience in the pharmaceutical industry Successful experience managing vendor relationships and alliance partnerships with at least 4 years experience in this area 3 years of line management experience.

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.

This Job Posting Excludes CO Applicants EEO Verbiage for US Reqs Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time