Sr. Manager, Clinical Data Management

Company: Takeda Pharmaceutical
Location: Clifton
Posted on: May 11, 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 DescriptionTakedaTakeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.Clinical Data Solutions (CDS) at TakedaKey to Takeda's success is the Clinical Data Solutions Team (CDS), providing Strategic planning, resourcing and oversight of clinical trial data deliverables.CDS engages in strategic partnerships, overseeing expert CROs to ensure successful execution and delivery of Clinical Data. CDS also owns Takeda's strategy for the development and governance of Data Standards, with the CDISC (Clinical Data Interchange Standards Consortium) industry standards. CDS performs oversight of all Study-level data capture (e.g., EDC, IVR, ePRO, eCOA) technologies and other related vendors and applications.Senior Manager, Clinical Data ManagementAs the Senior Manager Clinical Data Management, you will oversees and high-quality 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 project 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.You will be an expert for clinical data management, whether directly or by way of managing other [junior] CDS Staff. You will lead team members to perform proper Data Reviews, and provide guidance on CDISC standards.Key Accountabilities

• Manage 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 Team members 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 teams 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.
• Be a process expert for operational and oversight models.
• Maintain SOPs, process maps and templates and timelines to support departments operational and oversight models.
• May prepare metrics to support the function's Goals.
• 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 or lead functional Continuous Improvement plans, providing strategic direction and identifying essential deliverables that meet timelines, budget, and are with company, departmental or requirements.
• Ensure compliance with own Learning Curricula, corporate and GXP requirements.
• Work to ensure the quality of the data in each database delivery, and quality of other data management deliverablesEducational Qualifications
  • BS/BA required preferably in a health-related, life science area or technology-related fields.Experience
    • Preferred 6-8 years or equivalence experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
    • Proven track record of strong project management skills 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.
    • Strong knowledge of data management best practices & technologies as applied to clinical trials.
    • Solid understanding of 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 cross-functional interfaces with the data management function.Location: Cambridge - VirtualBase Salary Range: $150,000-170,000 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 excludedThis posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seqAbsent 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 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.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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