Manager, Clinical Data Solutions Early Oncology

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Job Description

As the Manager Clinical Data Management, you will manage data management deliverables supporting the Takeda portfolio. You will conduct oversight of Data Management activities at the project level performed by Takeda or Strategic Partners, CROs or other 3rd Party Vendors to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work. You will bring adherence to CDM processes from protocol synopsis through database release and submission.

You will be the first contact for CRO partners looking for sponsor input on study level problems. You will contribute to the management of all study vendors to ensure asset and study level strategies are being implemented during the conduct of Clinical Studies as verified in contractual assumptions in study SOWs (including monthly invoices).

You will be an expert for clinical data management best practices, engage with team members to perform proper Data Reviews and acts as an ambassador on CDISC standards.

Key Accountabilities

• Participate in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially to support important decisions and regulatory submissions.
• Be a first contact for CROs partners when collaboration is needed to ensure established deliverables are met with the highest degree of quality.
• Partner with appropriate team members and CRO partners to reduce and resolve risks.
• For studies where data management activities are conducted within Takeda, manages clinical trial data collection set-up, data review, and database lock: (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans. (c) Leads data review, including query management, and leads activities required for interim and final database locks.
• Participate in preparing function for submission readiness and may represent function in a formal inspection or audit.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Track study deliverables and Evaluate study metrics to mitigate risk for major data management deliverables.
• 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 Measurements.
• Represent function in external professional projects and organizations such as SCDM, CDISC, DIA to identify industry best practice and increase the visibility of Takeda.
• Contribute to functional Continuous Improvement plans, providing expertise and ensuring deliverables are provided on time, to budget, and with company, departmental or requirements.
• Ensure the quality of the data in each database delivery, and quality of other data management deliverables
• Champion and adopt technology improvements and tools for use in clinical data management processes.
• Ensure compliance with own Learning Curricula, corporate and GXP requirements.

Educational Qualifications

• BS/BA required preferably in a health-related, life science area or technology-related fields.

Experience

• 4 years or equivalent experience in data management and drug development process with expertise in the interfaces with the data management function.
• Experience with project management and managing data management activities for large drug development programs.
• NDA/CTD Experience.
• Knowledge of data management best practices & technologies as applied to clinical trials.
• Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Location: Cambridge OR Virtual

Base Salary Range: $120,000-140,000 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. If candidate is not eligible for any benefits or other comp., those can be excluded

This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq

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. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. 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. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you 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.

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