Senior Clinical Data Manager – FSP, GI

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee clinical data management studies involving healthy volunteers and patient populations, multi-site studies, intricate protocols, effective client management, or expedited timelines.

• Act as the Study Manager responsible for all DM deliverables, team directives, output assessments, and resource distribution.

• Ensure adherence to protocols, globally harmonized SOPs, and GCP standards throughout projects.

• Collaborate with Project Managers or FSP Leads to establish timelines that meet contracted milestones.

• Lead DM project teams and facilitate internal data-oriented meetings.

• Coordinate EDC Design, SAS Programming, Statistics, and PK deliverables.

• Identify potential risks and develop mitigation strategies, communicating data-driven insights to meet database lock deadlines.

• Supervise Biometrics deliverables, project advancement, budgets, scope alterations, and timeline ramifications.

• Manage the receipt and inventory of clinical and vendor data, ensuring project documentation is complete.

• Cultivate client relationships, review satisfaction surveys, and implement process enhancements and team training.

• Monitor scope changes and secure Sponsor approval as necessary.

• Provide leadership, mentorship, coaching, and subject matter expert (SME) guidance to DM study teams.

• Assist in performance evaluations and support the career development of team members.

• Explore and assess new DM technologies and methodologies.

• Ensure service quality aligns with DMP and scope-of-work specifications.

• Draft, review, and revise SOPs and associated documents.

• Reconcile clinical databases with safety, laboratory, and third-party data.

• Represent DM/Biometrics during new business pursuits and bid defense meetings.

• Participate in and address client or internal audits, resolving any issues that arise.

• Advocate for Biometrics services to sponsors.

• Undertake other assigned responsibilities.

⛳️ Requirements

• University or college degree required.

• Relevant education and work experience equivalent to a bachelor's degree will be accepted in place of a bachelor's degree.

• Fortrea may consider relevant and equivalent experience in lieu of educational qualifications.

• Must possess experience within the GI Therapeutic Area.

• Proficiency in English for speaking, writing, and reading is essential.

• A minimum of 8 years of combined early or late-stage DM experience is required.

• At least 2 years of direct sponsor management experience is necessary.

• Minimum of 2 years of experience in technical mentoring.

• Demonstrated experience in managing customer negotiations and overseeing Scope of Work and budgets.

• Comprehensive knowledge of the clinical trial process, DM, clinical operations, biometrics, and system applications that support operations.

• Proven track record of leading project strategies and achieving departmental goals, objectives, and initiatives.

• Familiarity with the CRO industry's relationship and regulatory responsibilities with pharmaceutical/biotechnology companies.

• Strong time management skills and ability to meet project productivity metrics and timelines.

• Ability to work collaboratively in a team environment with peers.

• Capability to mentor junior department members, providing SME advice on DM practices.

• Experience representing DM in bid defense meetings is a plus.

• Excellent organizational, communication, and interpersonal skills are required.

• A constructive problem-solving mindset with a focus on meeting deadlines is essential.

• Preferred: university/college degree in life sciences, health sciences, information technology, or related fields.

• Preferred: four or more years of experience with Electronic Data Capture.

• Preferred: in-depth knowledge of Fortrea, its organizational structure, and SOPs.

🏝️ Benefits

• Comprehensive health insurance plans.

• Competitive salary with performance bonuses.

• Opportunities for professional development and continuous learning.

• Flexible working hours and remote work options.

• Supportive and collaborative work environment.