Senior Clinical Data Manager - Remote, Canada based

Posted Yesterday
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Hiring Remotely in Canada
Remote
84K-145K Annually
Senior level
Biotech
The Role
Lead clinical data management from start-up to database lock for oncology studies, manage sponsor relationships, timelines, budgets, and junior DM staff; coordinate with biometrics, EDC, SAS, statistics and PK teams; identify risks/mitigations and ensure GCP/SOP compliance.
Summary Generated by Built In

Job Overview:

We are seeking a Senior Data Manager to take leadership in client-facing activities along with on studies. This individual will take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. In addition, this individual will assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. The incumbent will act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors. The Sr. Data Manager will work directly with Sponsors to understand their direct requirements and lead implementation of those requirements and will regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea. The Senior Clinical Data Manager will work with the leadership team to provide guidance, mentoring and training to DM to ensure best working practices are maintained.

Summary of Responsibilities:

  • 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.

Qualifications (Minimum Required):

  • 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.

  • Language Skills Required:

  • Speaking/Writing/Reading: English required.

Experience (Minimum Required):

  • 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.

  • Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.

Preferred Qualifications Include:

  • University / college degree (life sciences, health sciences, information technology or related subjects preferred).

  • Through knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs).

  • Four or more years of Electronic Data Capture experience.

Physical Requirements:

  • Frequently stationary for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Regular and consistent attendance.
  • Varied hours may be required.

Pay Range: $84,000-$145,000 CAD/ annually

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. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.

Application Deadline: 8/1/2026

#LI Remote

Learn more about our EEO & Accommodations request here.

Skills Required

  • Bachelor's degree (life sciences, health sciences, IT) or equivalent experience
  • English speaking, writing, and reading skills
  • Minimum 5 years combined early or late-stage oncology study DM experience
  • Minimum 5 years of direct sponsor management experience
  • Proven experience handling customer negotiations and managing Scope of Work and budgets
  • Thorough knowledge of clinical trial process, data management, clinical operations, biometrics, and supporting system applications
  • Proven ability to lead project teams, mentor staff, and drive department goals
  • Working knowledge of CRO relationship and regulatory obligations with pharmaceutical/biotech companies
  • Experience representing data management in bid defense meetings and providing client solutions
  • Constructive problem-solving attitude and ability to meet deadlines with incomplete information
  • Four or more years of Electronic Data Capture (EDC) experience
  • Knowledge of Fortrea organizational structure and Standard Operating Procedures (SOPs)
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The Company
HQ: Durham, NC
10,811 Employees

What We Do

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

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