Clinical Data Management Lead

hace 7 horas


San José, San José, Costa Rica Labcorp A tiempo completo

Job Summary

This role leads studies involving healthy volunteer and patient populations, multi-site complex protocol design, and strong client management. The successful candidate will be accountable for DM deliverables, providing instruction to their study team and reviewing their output to ensure high quality.

Key Responsibilities

  • Ensure all allocated projects are carried out in accordance with protocols, SOPs, and GCP standards.
  • Work with the Project Manager or FSP Lead to build timelines, communicate with leads in different disciplines, and meet contracted milestones.
  • Provide DM project team leadership, accountability, and meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK.
  • Maintain awareness of other Biometrics functional group deliverables, support risk and mitigation strategies, and consult with Project Manager and/or functional group management as necessary.
  • Keep Project Manager, Biometrics management team, and sponsor services informed of pertinent project or sponsor related information.
  • Coordinate the receipt and inventory of data related information from clinical sites and vendors.
  • Ensure all appropriate documentation and procedures are performed upon project completion.
  • Develop and maintain client relationships, review client satisfaction surveys, implement action plans, drive process improvements, and team training.
  • Track scope changes, work with the Project Manager or FSP Lead to ensure Sponsor approval, and process scope change.
  • Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
  • Support DM supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills, and achievement of competency standards.
  • Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Labcorp.
  • Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
  • Maintain accurate records of all work undertaken.
  • Perform reconciliation of the clinical database against safety data, laboratory data, or any other third-party data as appropriate.
  • Represent DM and where necessary overall Biometrics in new business opportunities.
  • Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe.
  • Address client comments with the study team.
  • Works with management team to develop and implement directional strategy by providing technical input into discussions and rolling out training/mentorship to DM staff (as required).
  • Actively promote Biometrics services to sponsors whenever possible.
  • Performs other related duties as assigned by management.


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