Offer summary

Qualifications:

University or college degree, preferably in life sciences, health sciences, or information technology., 5 years of experience in Oncology study data management with direct sponsor management., Thorough knowledge of clinical trial processes, data management, and biometrics., Proven ability to lead project strategies and manage client relationships effectively..

Key responsabilities:

Lead and manage data management activities from study start-up to database lock.

Ensure compliance with protocols, SOPs, and GCP standards throughout the project lifecycle.

Collaborate with project managers and study leads to build timelines and coordinate deliverables.

Provide leadership and mentoring to junior data management staff, ensuring best practices are followed.

Job description

If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

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.
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 Demands/Work Environment:

Role is remote-based, with associated risks of repetitive strain injury (associated with keyboard operation) and eye strain (associated with VDU screen operation).

Pay Range: CAD 84,000-150,000/ 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.

Application Deadline: May 2nd, 2025

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