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Lifelancer
Lifelancer
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Lifelancer जीवन विज्ञान, फार्मास्यूटिकल और आईटी क्षेत्रों पर केंद्रित एआई-संचालित प्रतिभा भर्ती मंच है। यह कुशल पेशेवरों को अपना अनुभव प्रस्तुत करने, अंतरराष्ट्रीय नौकरियों और परियोजना अवसरों की खोज करने तथा विशेष प्रतिभा की तलाश कर रहे नियोक्ताओं से जुड़ने में मदद करता है। भर्ती टीमों के लिए, Lifelancer एआई-सहायता प्राप्त प्रतिभा खोज को कई देशों में भर्ती और पेरोल संबंधी सहायता के साथ जोड़ता है, जिसमें अनुपालन संबंधी विचार भी शामिल हैं।
LinkedIn
कंपनी की नौकरियाँ

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.

USसंयुक्त राज्य
$85,000 – $95,000 / वर्ष
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Google Cloud Platform

विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • 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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