Senior Clinical Data Manager – FSP, GI

Fortrea

. Lead clinical data management studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, strong client management, or reduced timelines.

Posted 11/12/2026full-timeRemote • CanadaSenior💰 CA$115,000 - CA$125,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Clinical Data Management, including leadership in multi-site studies and compliance with GCP standards. Proven ability to manage client relationships, mentor teams, and ensure project deliverables meet timelines and quality specifications.

Highest-signal resume keywords

Clinical Data ManagementSponsor ManagementBiometrics Deliverables MonitoringElectronic Data CaptureGI Therapeutic Area Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ProcessData ManagementProject ManagementSAS ProgrammingStatistical AnalysisRisk IdentificationScope ManagementBudget ManagementSOP WritingDatabase Reconciliation

Soft Skills

LeadershipMentoringCommunicationProblem-SolvingTeam Collaboration

Tools & Technologies

Electronic Data Capture SystemsClinical DatabasesBiometrics SystemsProject Management ToolsStatistical Software

Industry Keywords

GCP StandardsCRO IndustryPharmaceutical CompaniesBiotechnological CompaniesClinical Operations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead clinical data management studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, strong client management, or reduced timelines.
Serve as Study Manager accountable for all DM deliverables, team instructions, output review, and resource allocation.
Ensure projects comply with protocols, global harmonized SOPs, and GCP standards.
Build timelines with Project Managers or FSP Leads to meet contracted milestones.
Lead DM project teams and internal data-focused meetings.
Coordinate EDC Design, SAS Programming, Statistics, and PK deliverables.
Identify risks and mitigations and communicate data-driven discussions to achieve database lock dates.
Monitor Biometrics deliverables, project progress, budgets, scope changes, and timeline impacts.
Coordinate receipt and inventory of clinical and vendor data and complete project documentation.
Manage client relationships, review satisfaction surveys, and implement process improvements and team training.
Track scope changes and obtain Sponsor approval.
Provide leadership, mentorship, coaching, and SME guidance to DM study teams.
Support performance evaluations and career development of team members.
Learn and evaluate new DM technologies and processes.
Ensure service and quality meet DMP and scope-of-work specifications.
Write, review, and update SOPs and related documents.
Reconcile clinical databases against safety, laboratory, and third-party data.
Represent DM/Biometrics in new business opportunities and bid defense meetings.
Attend and address client or internal audits and resolve issues.
Promote Biometrics services to sponsors.
Perform other assigned duties.

Requirements

What you’ll need

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.
Must have experience working within the GI Therapeutic Area.
English required for speaking, writing, and reading.
8 years of combined early or late-stage DM experience.
Minimum 2 years of direct sponsor management experience.
At least 2 years of technical mentoring experience.
Proven experience handling customer negotiations and 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 project strategies and achieve department goals, objectives, and initiatives.
Working knowledge of the CRO industry’s relationship and regulatory obligations with pharmaceutical/biotechnological companies.
Time management skills and ability to adhere to project productivity metrics and timelines.
Ability to work in a team environment and collaborate with peers.
Ability to mentor junior department members, providing SME guidance on DM practices.
Experience representing DM in bid defense meetings.
Good organizational, communication, and interpersonal skills.
Constructive problem-solving attitude while deadline focused.
Preferred: university/college degree in life sciences, health sciences, information technology, or related subjects.
Preferred: four or more years of Electronic Data Capture experience.
Preferred: thorough knowledge of Fortrea, its organizational structure, and SOPs.