Associate Director, Clinical Data Management

Company: Takeda Pharmaceutical
Location: Wayne
Posted on: May 13, 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 DescriptionREMOTE OPTION AVAILABLE OBJECTIVE: As the Associate Director, Clinical Data Management 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:
  • Minimum 8 years' data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
  • Experience managing vendor relationships and alliance partnerships with at least 4 years' experience in this area.
  • Minimum 3 years' of line management experience or equivalent
  • Project management experience and experience managing data management activities for large drug development programs.
  • Experience with all phases of development in one or more therapeutic areas preferred.
  • Ability to handle multiple development programs simultaneously.
  • NDA/CTD Experience preferred.
  • Expert knowledge of data management best practices, standards library development and maintenance.
  • Understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
  • Knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.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 ProgramsLocation: Cambridge, MA or 100% VirtualBase Salary Range: $160,000-190,000 based on candidate professional experience level. Employee may also be eligible for Short-term and Long-term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off.This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq.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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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