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Manager, Clinical Technology and Data Governance

Company: Takeda Pharmaceutical
Location: Revere
Posted on: November 19, 2021

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 DescriptionLocation: REMOTE BASED OPPORTUNITYOBJECTIVES: As the Manager, Clinical Technology and Data Governance, you will manage the Clinical Technology Management and Data Governance activities within Clinical Metrics, Analytics and Technology (CMART). The categories below are the Clinical Technology Manager primary responsibilities:

  • Technology Innovation and Data Governance
  • End-user Training and Support
  • Operational Data Quality MonitoringACCOUNTABILITIES: Manage the Clinical Technology and Support Team within CMART including:Technology Innovation and Data Governance
    • Be an R&D Data Domain Working Group Manager for Global Development Support (GDS) including working with stakeholders to prepare and facilitate governance meetings; Ensure essential decisions are maintained, participate in data cataloging and monitoring of data quality
    • Be a Business System Expert for Global Clinical Operations (GCO) and Global Development Support (GDS) operational systems (e.g., Veeva Vault Clinical, Nexus, CTMS ) and representative to provide inputs into R&D systems; Manage and escalate issues to BSO
    • Work with Business System Owner(s) and business process SMEs/ team members to manage system implementation and enhancements ensuring compliance with system development life cycle and 21 CFR Part 11 requirements (as applicable and in collaboration with IT and QA); Support BSO in giving feedback on the status updates on technology implementations to appropriate management and governance forums
    • Partner with IT Technology Leads and Team members to resolve system issues and help determine enhancements
    • In collaboration with the Data Sciences Institute (DSI) and Clinical Information Operations (CIO), manage the vendor operational data feeds into data hub and data quality checks tools; Work with DSI, CIO, vendors and partners to maintain data transfer specifications and ensure resolution of any data quality issues identified (as applicable)
    • Seek opportunities to participate in process optimization plans; Provide input and identify opportunities to use operational data and technology to further improve an outsourced trial operating model including considerations for oversight requirements, predictable trial delivery and industry best practicesData Quality Monitoring
      • Be a data steward for GCO and GDS managed operational systems and inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements )
      • Participate in the development and monitoring of the operational data quality checks in collaboration with partners
      • Manage a central support process to work with data owners and vendors to ensure source system data updates are made to support operational reporting, clinical trial listing regulatory reporting and ensure inspection readiness
        • Promote and implement measures to support a positive workplace, collaboration, and talent development for Clinical Technology Management and Support teamEDUCATION:Education: Bachelor's degreeExperience:
          • 3+ years of experience with in pharmaceutical, CRO, healthcare or related industry
          • Experience within clinical trial operations and clinical trial lifecycle
          • Experience in process development management, inspection readiness, TMF and clinical systems
          • Understanding of system development lifecycle requirements and of US CFR, GCP, ICH and the clinical development process
          • Experience within a global regulatory environment is desirableTRAVEL REQUIREMENTS:
            • Requires approximately 5-10% travel, including overnight and international travel to other Takeda sites to support regulatory inspections.Base Salary Range: $115,000-145,000 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 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 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Revere , Manager, Clinical Technology and Data Governance, Healthcare , Revere, Massachusetts

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