Senior Manager, Clinical Data Management Compliance ...

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I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionSenior Manager, Clinical Data Management (CDM) Compliance & Quality Innovations - REMOTEOBJECTIVES/PURPOSE Responsible for monitoring and reporting on quality of DM processes and other DM-related cross-functional processes that enable quality databasesYou will be a member of an independent team of Quality-focused SMEs deployed across TAUs to perform quality assessments of selected processesYou will build of a Quality Management framework in close partnership with the Associate Director of CDM Compliance & Quality Innovations, CDM LT.SCOPE As the Senior Manager, Clinical Data Management (CDM) Compliance & Quality Innovations, you will oversee end-to-end accuracy and completeness of data for clinical trial submission and other secondary uses through systematic and independent assessments of processes and/or activities impacting data management or its deliverables. ACCOUNTABILITIES Perform data management quality process oversight and ensuring proper execution of prioritized cross-functional processes related to timely delivery of quality study Databases (e.g., Quality Gates, Data Review Process), and manage staff responsible for performing those activities.Perform routine evaluation of processes to determine adherence to procedural documentation through active process engagement by study team functional representatives, and adherence to study milestone cycle times.Perform oversight & management of TAU-specific data quality standards deployment, application (adoption), and fit for purpose from a Clinical Data Management perspective to ensure the accuracy, completeness, reliability, relevance, and timeliness of data and CDM related documents.May develop KPIs, metrics and dashboards to track process quality, efficiency and complianceEngage with CDM Study Leads to provide near real-time feedback on study data quality and team performance on evaluated processes.Act as a process expert for operational and oversight models.Maintain SOPs, process maps and templates and timelines to support functions operational and oversight models.Represent function in external professional initiatives and organizations such as SCDM, DIA, etc. to identify industry best practice and increase the visibility of Takeda.Contribute and Lead functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.Work cross-functionally to ensure the quality of the data in each database, on time delivery, as well as ensure 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.DIMENSIONS AND ASPECTS Medium complexity projects and/or platforms.Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be requiredModerate supervision required, should be able to function collaboratively with all levels of employees.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS EducationBS/BA in a health-related, life science, quality assurance or instructional design areas or technology-related field preferred or equivalent combination of education, training and experienceExperienceMinimum 6 years'' or equivalence experience in data management and drug development process with expertise in the cross-functional interfaces with the data management functionExperience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.Project management experience managing data management coding activities for large drug development programs.Experience with GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, Vaccines and/or vaccine.Experience handling development programs simultaneously.NDA/CTD Experience preferred.Experience with data management best practices & technologies as applied to clinical trials.Experience with broad drug development process with expertise in the cross-functional interfaces with the data management function.Experience with FDA and ICH regulations and industry standards applicable to data capture and data management process.Special SkillsStrong knowledge of relational databases and experience using multiple clinical data management systemsAdvanced knowledge of office software (Microsoft Office).Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.Expert knowledge of general or medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processesJob Complexity/Travel:* High complexity at program that include multiple projects and/or platforms.* Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required.Supervision* Minimal supervision required, should be able to function independently and collaboratively with all levels of employees.WHAT TAKEDA CAN OFFER YOU:401(k) with company match and Annual Retirement Contribution PlanTuition reimbursement Company match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity 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 seqEEO 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 LI-Remote

Created: 2025-10-04