Senior Clinical Data Manager – FSP, GI

🔥 4 minutes ago

🇨🇦 Canada – Remote

💵 $115k - $125k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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

• 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.

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