Senior Clinical Data Manager

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, intricate protocols, client management, and expedited timelines.

• Take responsibility for all data management deliverables and offer guidance and quality oversight for data management study teams.

• Ensure adherence to protocols, globally harmonized standard operating procedures (SOPs), and Good Clinical Practice (GCP) standards throughout the projects.

• Collaborate with Project Managers, Functional Service Provider (FSP) Leads, and cross-functional leaders to develop timelines that meet contracted milestones.

• Facilitate data-driven internal project meetings and synchronize deliverables with EDC Design, SAS Programming, Statistics, and Pharmacokinetics (PK) teams.

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

• Monitor deliverables from Biometrics, project progression, budgets, scope alterations, and impacts on timelines.

• Manage the receipt and inventory of clinical and vendor data while ensuring all project completion documentation is in order.

• Cultivate client relationships, review satisfaction surveys, implement action plans, and enhance processes and team training.

• Track any changes in scope and secure Sponsor approval.

• Provide leadership, mentoring, coaching, and technical expertise to data management staff.

• Assist with performance assessments and the professional development of team members.

• Acquire knowledge of and assess new data management technologies and processes for potential improvements.

• Ensure that services and quality align with data management plan (DMP) and scope-of-work specifications.

• Draft, review, and update SOPs and related documentation.

• Maintain precise work records.

• Reconcile clinical databases with safety, laboratory, and third-party data using local lab systems and batch data loads as necessary.

• Represent Data Management/Biometrics in business opportunities and bid defense meetings.

• Attend to and resolve issues arising from client or internal audits.

• Promote Biometrics services to sponsors and perform additional assigned tasks.

⛳️ Requirements

• University or college degree.

• Relevant work experience combined with education equating to a bachelor's degree will be accepted in place of a bachelor’s degree.

• Fortrea may consider relevant and equivalent experience as a substitute for educational qualifications.

• Proficiency in English, including speaking, writing, and reading.

• A minimum of 8 years of combined experience in early or late-stage data management.

• At least 2 years of direct experience in sponsor management.

• A minimum of 2 years of experience in technical mentoring.

• Proven experience in handling customer negotiations.

• Experience managing Scope of Work and budgets.

• Comprehensive understanding of the clinical trial process, data management, clinical operations, biometrics, and supportive system applications.

• Demonstrated ability to lead project strategies as well as departmental goals, objectives, and initiatives.

• Familiarity with CRO industry relationships and regulatory obligations pertaining to pharmaceutical and biotechnological companies.

• Strong time management skills with the ability to meet project productivity metrics and deadlines.

• Capability to work within a team environment and collaborate effectively with colleagues.

• Ability to mentor junior team members and provide subject matter expert guidance on data management practices.

• Experience representing data management in bid defense meetings.

• Excellent organizational, communication, and interpersonal skills.

• A constructive approach to problem-solving while maintaining focus on deadlines.

• 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: Understanding of Fortrea organization and its SOPs.

🏝️ Benefits

• Possible travel for cross-site support or training needs, with meetings occurring up to 10% of the time, and up to 50% of that time may require an overnight stay.

• Compensation will take into account skills, relevant prior experience, applicable degrees/certifications, internal equity, and market data.