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Associate Manager, Clinical Data Management

Lead clinical data management for Fortrea clinical trials, coordinating study teams, data reconciliation, validation, sponsor requirements, and database lock delivery.

USStatele Unite ale Americii
85.000 $ – 95.000 $ / an
RemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Manage clinical data activities across studies from start-up through database lock
  • Oversee project documentation, system configuration, data entry, and validation procedures
  • Partner with sponsors to clarify and implement study requirements
  • Manage studies involving healthy volunteers or patients, multiple sites, client oversight, or compressed timelines
  • Plan and prioritize workloads and deliverables
  • Own data management deliverables, direct study teams, review outputs, and realign resources as needed
  • Ensure study work follows protocols, globally harmonized SOPs, and GCP requirements
  • Develop study timelines with Project Managers to achieve contracted milestones
  • Lead data management meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams
  • Identify risks and mitigations, facilitate data-focused discussions, and support database lock milestones
  • Update Project Managers, Biometrics leadership, and sponsor services on progress, budgets, scope changes, and schedule effects
  • Build client relationships and evaluate client satisfaction feedback
  • Monitor scope changes and secure sponsor approval
  • Lead, mentor, coach, and provide constructive feedback to study team members
  • Adopt new data management technologies and processes to improve delivery
  • Maintain complete and accurate work records
  • Reconcile clinical databases with safety, laboratory, and third-party data
  • Use local laboratory systems and batch data-loading capabilities when appropriate
  • Represent Data Management and Biometrics in new business opportunities
  • Participate in client and internal audits, take required actions, and resolve findings
  • Coordinate responses to client comments with the study team
  • Promote Biometrics services to sponsors
  • Complete other assigned duties

Cerințe

  • A university or college degree is required; relevant equivalent experience may substitute for formal education
  • A bachelor’s degree may be substituted with an equivalent combination of education and relevant work experience
  • Fluent written and spoken English
  • About 3 years in a primary data management role on complex in-house studies, or at least 5 years of hands-on data review and reconciliation experience
  • Six to eight years of data management experience, including at least one year managing sponsors directly
  • Experience supporting in-house study start-up, conduct, and closeout
  • Experience creating or updating Data Management Plans, eCRF Completion Guidelines, Data Review Plans, SAE Reconciliation Plans, and edit check specifications
  • Experience conducting EDC database user acceptance testing and reviewing data validation listings
  • Proficiency reconciling complex external data, including eCOA, PK, local laboratory ranges, and biomarkers
  • Experience performing EDC data cleaning
  • Ability to raise EDC queries from monthly cross-functional data review findings
  • Experience maintaining issue logs
  • Experience uploading documents to an eTMF
  • Experience reporting metrics during team meetings
  • Experience reconciling protocol deviations
  • Experience supporting database lock activities
  • Strong communication abilities
  • Comfort working on fast-paced studies
  • Knowledge of clinical trial processes, data management, clinical operations, biometrics, and related system applications
  • Strong time management and ability to meet productivity measures and project deadlines
  • Knowledge of medical terminology
  • At least 3 years of Electronic Data Capture experience
  • Previous Veeva EDC experience is preferred
  • A degree in life sciences, health sciences, information technology, or a related field is preferred
  • A scientific background or knowledge of science is preferred
  • Detailed knowledge of Fortrea’s organization and SOPs is preferred
  • Availability for occasional overtime and weekend work may be required
  • Willingness to work flexible shifts as needed

Beneficii

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Short- and long-term disability coverage
  • 401(k) plan
  • Paid time off or flexible time off
  • Company bonus where applicable
  • Flexible shifts based on business needs
  • Office-based and home-based work environments

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