As the Senior Manager Clinical Data Solutions, you will oversee data management deliverables supporting the Takeda portfolio. You will report to the Director of Clinical Data Solutions. You will conduct oversight of Data Management activities at the program level - as performed by Strategic Partners, CROs or other 3rd Party Vendors to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.Key Accountabilities
- Oversee vendor oversight activities across global development programs. 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.
- Contribute influential leadership in collaboration with other Takeda Partners to ensure established deliverables are met with the highest degree of quality.
- Partner with appropriate team members and CRO partners to avoid and resolve risks.
- Provide input to functional governance with Takeda's strategic suppliers. Partner with appropriate team members to resolves issues escalated from the vendor and teams.
- Participate in preparing function for submission readiness and may represent function in a formal inspection or audit.
- Represent function in formal inspections and audits.
- Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
- Ensure achievement of major data management deliverables with other departments including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
- Manage external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
- May prepare metrics to support the function's Indicators.
- Represent function in external professional plans and organizations such as SCDM, CDISC, DIA to identify industry best practice and increase the visibility of Takeda.
- Ensure compliance with own Learning Curricula, corporate and GXP requirements.
- BS/BA in a health-related, life science area or technology-related fields or equivalent in experience.
- 8 years' data management and drug development process with expertise in the data management function.
- Project management experience managing data management activities for large drug development programs.
- Experience with the various phases of development in one or more therapeutic areas.
- Experience with SDTM
- Experience with eCOA/IRT
- NDA/CTD Experience
- Knowledge of data management best practices and technologies as applied to clinical trials.
- Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
- Advanced knowledge of broad drug development process with expertise in the data management function.
- Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
- Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required.
Location: Cambridge, MA or 100% Virtual
Base Salary Range: $150,000-175,000 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.
Effective 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 Statement
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, MAWorker Type