Fortrea

Senior Clinical Data Manager

Fortrea

full-time

Posted on:

Location Type: Remote

Location: Canada

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 CA$84,000 - CA$145,000 per year

Job Level

Senior

About the role

  • Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines.
  • Ability to organize and effectively prioritize workload and deliverables.
  • As the Study Manager, be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly.
  • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
  • Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings.
  • Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager or FSP Lead (or designee) apprised of project progress.
  • Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary.
  • All other duties as needed or assigned.

Requirements

  • University / college degree (Bachelor’s degree or equivalent experience in life sciences, health sciences, or IT)
  • Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • 5 years of combined early or late-stage Oncology study DM experience with minimum 5 years of direct sponsor management.
  • Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
  • Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
  • Proven ability to lead by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
  • Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs.
Benefits
  • All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
data managementclinical trial processbiometricsEDC designSAS programmingstatisticsproject managementrisk mitigationscope of work managementbudget management
Soft skills
client managementorganizational skillsleadershipcommunicationproblem-solvingteam collaborationnegotiationaccountabilityprioritizationadaptability