Senior Clinical Data Manager – Oncology

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

📋 Description

• Oversee data management throughout clinical studies from the initiation phase to database lock.

• Take charge of project documentation, system configuration, data entry, and validation procedures.

• Serve as the subject matter expert for data management in meetings with sponsors.

• Comprehend sponsor requirements and spearhead implementation efforts.

• Evaluate client-specific processes and drive enhancements.

• Offer guidance, mentoring, and training to the data management team.

• Manage studies involving healthy volunteers and patient populations, multi-site studies, complex protocols, client management, or expedited timelines.

• Function as the Study Manager accountable for data management outputs, instructions to study teams, review of outputs, and resource allocation.

• Ensure project compliance with protocols, globally harmonized SOPs, and GCP standards.

• Collaborate with Project Managers or FSP Leads to create timelines and coordinate with cross-functional project teams.

• Facilitate data-focused internal project meetings and align deliverables with EDC Design, SAS Programming, Statistics, and PK teams.

• Identify risks and mitigation strategies, communicate data-driven discussions, and support database lock deadlines.

• Oversee Biometrics deliverables and their impact on data management resources and timelines.

• Keep project, Biometrics, and sponsor services management updated on project status, budget, scope, and timelines.

• Manage the receipt and inventory of data-related information from clinical sites and vendors.

• Ensure all documentation and procedures are completed during project closeout.

• Foster client relationships, review satisfaction surveys, implement action plans, and drive process improvements and training initiatives.

• Track changes in project scope and obtain sponsor approval.

• Provide leadership, mentorship, and coaching in clinical trial data management processes and technical skills.

• Support performance evaluations and deliver constructive feedback for career development.

• Acquire knowledge of new data management technologies and processes, and support continuous improvement efforts.

• Ensure services and quality meet 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 other third-party data.

• Represent Data Management and Biometrics during new business opportunities and bid defense meetings.

• Participate in client or internal audits, addressing and resolving any issues.

• Develop and implement strategic direction, technical input, training, and mentorship.

• Advocate for Biometrics services to sponsors.

• Perform other related tasks as assigned.

⛳️ Requirements

• University or college degree.

• Relevant education and/or experience equating to a bachelor's degree may be accepted in lieu of a bachelor's degree.

• Equivalent relevant experience may also be considered in place of educational requirements.

• Proficiency in speaking, writing, and reading English is required.

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

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

• Minimum of 2 years of technical mentoring experience.

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

• 3-5 years of experience in Oncology is required.

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

• Proven ability to lead project strategies and meet departmental goals, objectives, and initiatives.

• Familiarity with CRO industry relationships and regulatory obligations involving pharmaceutical/biotechnological companies.

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

• Capability to work collaboratively in a team environment.

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

• Experience representing data management in bid defense meetings.

• Good organizational, communication, and interpersonal skills are essential.

• Constructive problem-solving mindset with a focus on deadlines.

• Preferred: University or 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.

• Ability to work in either an office or remote-based setting.

🏝️ Benefits

• Option for remote-based work.

• Potential travel for cross-site support or training purposes.

• Meetings may occur up to 10% of the time, with up to 50% of that time requiring an overnight stay.

• All job offers will be based on the candidate's skills and relevant experience, applicable degrees/certifications, internal equity, and market data.