Associate Clinical Data Manager – FSP, GI

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

📋 Description

• Oversee clinical data management studies that involve healthy volunteers and patient populations, including multi-site studies, client management, and expedited timelines.

• Take responsibility for data management deliverables, guide DM study teams, assess outputs, and modify resource allocations as necessary.

• Ensure that projects adhere to protocols, globally harmonized standard operating procedures (SOPs), and GCP standards.

• Collaborate with Project Managers to establish timelines and coordinate with cross-functional project leaders.

• Facilitate internal, data-centric project meetings and oversee EDC Design, SAS Programming, Statistics, and PK deliverables.

• Identify risks and mitigation strategies, engage in data-driven discussions, and support database lock schedules.

• Keep Project Managers, Biometrics management, sponsor services, and sponsors updated on project status, budgetary matters, scope alterations, and timeline effects.

• Develop client relationships and evaluate client satisfaction through surveys.

• Monitor scope modifications and secure Sponsor approval.

• Provide leadership, mentorship, and coaching in clinical trial data management methodologies.

• Assist in performance evaluations and the professional growth of team members.

• Acquire knowledge of new DM technologies and applied processes, driving improvements in processes.

• Maintain precise work records.

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

• Represent Data Management and Biometrics in new business ventures.

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

• Advocate for Biometrics services to sponsors.

⛳️ Requirements

• A university or college degree.

• Relevant and equivalent experience may be considered as a substitute for educational qualifications.

• Experience and/or education combined with relevant work experience equivalent to a bachelor's degree will be accepted in place of a bachelor's degree.

• Proficiency in English, both written and spoken.

• 6 to 8 years of experience in data management.

• At least 1 year of direct management experience with sponsors.

• Familiarity with the clinical trial process, data management, clinical operations, biometrics, and system applications to facilitate operations.

• Capability to meet project productivity metrics and deadlines.

• Understanding of medical terminology.

• A preference for 3+ years of experience with Electronic Data Capture.

• Experience in addressing customer concerns and managing Scope of Work and budgets is preferred.

• A background in science or knowledge of scientific principles is preferred.

• Comprehensive understanding of Fortrea, organizational structure, and Standard Operating Procedures is preferred.

🏝️ Benefits

• A work environment that accommodates both office and home-based settings.

• Flexible shifts according to business needs.

• Overtime and weekend work as required.