Associate Director, Clinical Data Solutions- Early Oncology

Company: Takeda Pharmaceutical
Location: Newark
Posted on: May 12, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionOBJECTIVE: As the Associate Director, Clinical Data Solutions you will report to the Director, Clinical Data Solutions and you will ensure the quality for all Data Management (DM) deliverables globally within a therapeutic area. You will provide oversight of DM budget in collaboration with program management. You will provide data management expertise and capability to support global development programs and post-marketing registration and non-registration studies. Contribute to management of strategic vendor partnerships to maximize effectiveness of external (CRO) resources.ACCOUNTABILITIES:

• Manage vendor oversight activities across all global development programs within a therapeutic area.
• Represent data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially to support essential decisions and regulatory submissions.
• Provide input to functional governance with Takeda's strategic suppliers.
• Partner with appropriate team members to resolves issues escalated from the vendor.
• Ensure achievement of major data management deliverables with other departments including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics:
• Design and implement data capture tools
• Data processing, coding and validation
• Manage the quality of the data in each database, and quality of other data management deliverables
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
• Oversee 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.
• Represent function in external professional projects and organizations such as SCDM, CDISC, DIA to identify industry best practice and increase the visibility of Takeda.Required EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:
  • BS degree in analytical or health-related field.
  • 10+ years' of data management experience in the pharmaceutical industry
  • 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
  • Knowledge of relational databases and experience using multiple clinical data management systems
  • Knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.WHAT TAKEDA CAN OFFER YOU:
    • 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 ProgramsThis Job Posting Excludes CO ApplicantsEffective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.EEO StatementTakeda 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 observing applicable federal, state and local laws, and any other characteristic protected by law.EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Newark , Associate Director, Clinical Data Solutions- Early Oncology, Executive , Newark, New Jersey