Senior Clinical Data Specialist

Senior Clinical Data Specialist at Fortrea

Join Fortrea as a Senior Clinical Data Specialist within our Functional Service Provider (FSP) model, where you will play a critical role in ensuring high-quality clinical data that supports global drug development. This fully remote position offers the opportunity to contribute meaningfully across clinical programs while collaborating with global teams.

This is a full-time, home-based position in Canada that will require willingness to work flexible hours as needed to meet business needs.

Key Responsibilities

• You will review clinical trial data in accordance with Global Data Management Plans and standardized data management processes to identify missing, incomplete, erroneous, or implausible data.
• You will run diagnostics, special listings, reconciliation discrepancy outputs, and other ancillary programs supporting clinical data review.
• You will generate, track, and resolve data queries to ensure high-quality, complete, and accurate clinical data.
• You will conduct aggregate data reviews by patient, site, and study level to identify patterns, inconsistencies, compliance issues, or potential safety concerns.
• You will apply quality control procedures ensuring all deliverables meet Fortrea and client data quality standards.
• You may review project documentation such as protocols, CRFs/eCRFs, Data Management Plans, and data review guidelines.
• You will assist in developing Data Management Plans, Quality Management Plans, and data review guidance documents.
• You will support review of database design, eCRF annotation, and development/testing of data validation checks and special listings.
• You may support the Lead Data Manager or Lead Data Reviewer in timeline planning, milestone tracking, and cross-functional coordination.
• You will support internal and client audits, address findings, and ensure documentation is compliant and inspection-ready.
• You may mentor or coach junior staff on project-specific and global processes.
• And all other duties as needed or assigned.

Required Qualifications

• Bachelor’s degree in life sciences, health sciences, information technology, or a related field; equivalent experience will be considered.
• 4–6 years of Clinical Data Management experience.
• Working knowledge of clinical trial processes, data management workflows, clinical operations, and biometrics.
• Strong time-management skills with the ability to meet productivity metrics and timelines.
• Ability to work effectively both independently and collaboratively.
• Strong organizational, interpersonal, and written communication skills.
• Knowledge of medical terminology or scientific background preferred.

Preferred Qualifications

• Strong understanding of Fortrea systems, SOPs, and organizational structure.
• Two or more years of Electronic Data Capture (EDC) experience.
• Prior experience in global studies or FSP-based delivery models.

Work Environment

Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with some domestic and international travel.

Physical Requirements

• Frequently stationary for 6–8 hours per day.
• Repetitive hand movements with the ability to make fast, simple, repeated motions using fingers, hands, and wrists.
• Occasional crouching and stooping; frequent bending and twisting of the upper body and neck.
• Ability to access and use various computer software applications developed in-house or off-the-shelf.
• Light to moderate lifting and carrying (e.g., luggage and laptop) up to 15–20 lbs.
• Regular and consistent attendance required.
• Varied hours may be required depending on project needs.

Key skills/competency

• Clinical Data Management
• Data Review
• Electronic Data Capture (EDC)
• Clinical Trials
• Data Quality Control
• Query Resolution
• Data Validation
• Global Studies
• Regulatory Compliance
• Mentorship