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Senior Clinical Data Manager - Remote within the US or Canada

Company: Labcorp
Location: Raleigh
Posted on: October 12, 2021

Job Description:

Job Overview:

Labcorp Drug Development has an exciting opportunity for a Senior Clinical Data Manager. The Senior Clinical Data Manager will be remotely (home-based) located anywhere within the United States or Canada.

 

  • Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc,) to identify erroneous, missing, incomplete, or implausible data.
  • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.
  • Interact with the dictionary coding and maintenance group to ensure appropriate process setup and application,
  • Perform reconciliation of the clinical and safety databases.
  • Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.).
  • Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation. Apply quality control procedures and checks to ensure data quality standards (client and Labcorp Drug Development) are achieved.
  • Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.
  • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
  • Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
  • Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
  • Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
  • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
  • Serve as client contact for project meetings and CDM status updates.
  • Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
  • Support the training of project staff on project-specific, global, standardized data management processes.
  • Maintain technical data management competencies via participation in internal and external training seminars.
  • Review literature and research technologies/procedures for improving global data management practices.
  • Perform other duties as assigned by management.

Education/Qualifications:

  • University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
  • Additional relevant work experience will be considered in lieu of formal qualifications.
  • Broad knowledge of drug development processes.
  • Understanding of global clinical development budgets and relationship to productivity targets.
  • Knowledge of effective clinical data management practices.
  • Knowledge of time and cost estimate development and pricing strategies.
  • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

Experience:

  • Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
  • Demonstrated skill for technical management of staff exceeding 5 employees.
  • Financial management of gross revenues in excess of $250K per year.
  • Excellent oral and written communication and presentation skills.
  • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
  • Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
  • Demonstrated managerial and interpersonal skills.

#LI-REMOTE

Keywords: Labcorp, Raleigh , Senior Clinical Data Manager - Remote within the US or Canada, Other , Raleigh, North Carolina

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