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Senior Manager, Clinical Data Management

Tango Therapeutics
Full-time
Remote friendly (Boston, MA)
United States
$143,200 - $214,800 USD yearly
Clinical Research and Development

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Role Summary

Reporting to the Associate Director of Clinical Data Management, the Senior Manager of Clinical Data Management will be responsible for managing clinical data management activities across Tangoβ€šΓ„Γ΄s clinical trials. This includes overseeing study-specific data management processes from trial planning through database lock. This role involves collaborating with cross-functional teams and external partners to ensure high-quality, timely clinical data, supporting the operational execution of clinical trials.

Responsibilities

  • Serve as the lead data management representative on cross-functional study teams
  • Manage day-to-day clinical data management activities with CROs and vendors to ensure timely and accurate data capture
  • Develop, review, and maintain study-specific data management documentation, including Data Management Plans (DMPs), CRF Completion Guidelines, and Data Review Guidelines
  • Provide leadership and oversight for user acceptance testing (UAT) of eCRFs and associated edit checks
  • Guide and monitor data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders
  • Establish, review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets
  • Partner with CROs to manage timelines and deliverables for data management activities
  • Contribute to database lock activities, ensuring audit readiness and data integrity
  • Maintain and ensure accuracy of study-specific trackers and metrics dashboards
  • Create and manage data deliverable timelines and tasks
  • Review and provide feedback on vendor data transfer agreements, transfers and reconciliation

Qualifications

  • BS with 5+ years of clinical data management experience in CRO, pharma, or biotech settings
  • Strong experience with Medidata Rave EDC systems and electronic trial master files (eTMF)
  • Demonstrated knowledge of ICH/GCP, FDA regulations, and clinical trial processes
  • Proficiency in industry data standards including CDISC, SDTM, and CDASH
  • Prior experience collaborating with CROs on clinical studies
  • Highly organized with excellent communication and interpersonal skills
  • Experience in small biotech environments highly preferred
  • Familiarity with data visualization or analytics tools such as R, SAS or elluminate
  • Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
  • Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
  • Ability to manage multiple projects in a fast-paced environment

Skills

  • Clinical data management leadership
  • Data quality management
  • Vendor and CRO coordination
  • eCRF/UAT oversight
  • Data standards (CDISC, SDTM, CDASH)
  • Medidata Rave and eTMF proficiency
  • Project management

Education

  • BS degree (required)

Additional Requirements

  • None specified
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