Senior Clinical Data Manager (Remote US or Canada)

Fortrea • Toronto, ON

2d • $80,000 - $145,000 • Remote

About The Position

This role provides leadership in Data Management (DM) on clinical studies, taking responsibility for developing project documentation, system setup, data entry, and data validation procedures. The Senior Clinical Data Manager will oversee all DM activities from study start-up to database lock, ensuring adherence to client quality expectations, project timelines, and budgets. This position acts as a Subject Matter Expert (SME) for DM activities in client meetings, working directly with sponsors to understand and implement their requirements. The role also involves reviewing client-specific processes for optimization and providing guidance, mentoring, and training to junior DM staff to maintain best working practices. The Senior Clinical Data Manager will collaborate with the leadership team to ensure these standards are upheld.

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.
• Minimum of 1-year Veeva EDC experience.
• Speaking/Writing/Reading: English required.
• 8 years of combined early or late-stage DM experience.
• Minimum 2 years of direct sponsor management.
• At least 2 years technical mentoring experience.
• Proven experience in handling customer negotiations.
• Experience with 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 by example on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
• Time management skill 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 members of the department, providing SME guidance on DM practices.
• Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs.
• Good organizational ability, communication, and interpersonal skills.
• Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.

Nice To Haves

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).
• Through knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs).
• Four or more years of Electronic Data Capture experience.

Responsibilities

• Lead studies, including those with healthy volunteer and patient populations, multi-site studies, complex protocol designs, requiring strong client management or reduced timelines.
• Organize and effectively prioritize workload and deliverables.
• As Study Manager, be accountable for all DM deliverables as assigned per the established timeline.
• Provide instruction to DM study teams and review their output to ensure the highest quality, adjusting resource allocations accordingly.
• Ensure all allocated projects are carried out in strict accordance with relevant protocols, global harmonized SOPs, and GCPs.
• Work with Project Managers or FSP Leads to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team.
• Provide DM project team leadership and accountability; lead data-focused internal project team meetings.
• Meet frequently with study leads of EDC Design, SAS Programming, Statistics, and PK to ensure deliverables are planned and coordinated intradepartmentally.
• Proactively identify potential risks/mitigations and effectively communicate data-driven discussions to achieve database lock dates.
• Keep the Project Manager or FSP Lead informed of project progress.
• Maintain awareness of other Biometrics functional group deliverables to support risk and mitigation strategies, including impact on DM resources or deliverables.
• Consult with Project Manager and/or functional group management as necessary.
• Keep Project Manager, Biometrics management team, and/or sponsor services informed of pertinent project or sponsor-related information.
• Coordinate the receipt and inventory of all data-related information from clinical sites and vendors.
• Ensure all appropriate documentation and procedures are performed upon project completion.
• Develop and maintain client relationships and review client satisfaction surveys.
• Implement appropriate action plans, including driving process improvements and team training.
• Track scope changes and work with the Project Manager or FSP Lead to ensure Sponsor approval and processing of scope changes.
• Provide leadership, mentorship, and coaching in DM-related clinical trial processes, department technical capabilities, and associated turnaround durations to the internal study team.
• Support DM supervisors and managers on performance evaluations of other team members, providing constructive feedback for career development.
• Be accountable for learning new DM technologies and applied processes, staying updated with industry-wide technology and feasibility for process improvement.
• Ensure service and quality meet agreed-upon specifications per the DMP and scope of work.
• Have input in writing, reviewing, and updating SOPs and associated documents.
• Maintain accurate records of all work undertaken.
• Perform reconciliation of the clinical database against safety data, laboratory data, or any other third-party data.
• Utilize local laboratory systems and batch data load facilities where appropriate.
• Represent DM and Biometrics in new business opportunities.
• Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe.
• Address client comments with the study team.
• Work with the management team to develop and implement directional strategy by providing technical input and rolling out training/mentorship to DM staff.
• Actively promote Biometrics services to sponsors.
• Perform other related duties as assigned by management.
• Perform all other duties as needed or assigned.

Benefits

• All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree