Senior Clinical Data Manager – Oncology

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

📋 Description

• Oversee clinical data management studies involving healthy volunteers and patient populations, multi-site studies, intricate protocols, client relations, or expedited timelines.

• Take ownership of data management deliverables from the initiation of the study until database lock.

• Create project documentation, establish system setup, and define data entry and validation procedures.

• Collaborate with Project Managers or FSP Leads to develop timelines that align with contracted milestones.

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

• Identify risks and mitigation strategies, and engage in data-driven discussions to meet database lock deadlines.

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

• Ensure compliance with protocols, globally harmonized SOPs, GCP standards, DMPs, and the scope of work.

• Maintain relationships with clients, review satisfaction surveys, and implement action plans and process enhancements.

• Monitor scope changes and obtain Sponsor approval.

• Provide leadership, mentorship, coaching, training, and performance evaluations to the data management team.

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

• Utilize local laboratory systems and batch data loading facilities.

• Assist with new business opportunities, bid defense meetings, audits, and sponsor-facing Biometrics activities.

• Contribute to the development of SOPs and maintain accurate work records.

• Keep stakeholders updated on project status, budgets, scope alterations, and timeline effects.

⛳️ Requirements

• Bachelor’s degree or university/college degree; relevant work experience equivalent to a bachelor's degree may be accepted.

• Equivalent and relevant experience may be considered in place of educational qualifications.

• Proficiency in English for speaking, writing, and reading is essential.

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

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

• Minimum of 2 years of experience in technical mentoring.

• 3 to 5 years of experience in Oncology.

• Experience in customer negotiations and managing Scope of Work and budgets.

• Comprehensive understanding of clinical trial processes, data management, clinical operations, biometrics, and relevant system applications.

• Familiarity with CRO regulatory responsibilities and relationships with pharmaceutical/biotechnology companies.

• Capability to adhere to project productivity metrics and timelines.

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

• Experience representing data management in bid defense meetings is valued.

• Preferably four or more years of experience with Electronic Data Capture.

• A degree in life sciences, health sciences, information technology, or related fields is preferred.

• Knowledge of Fortrea’s organization and SOPs is advantageous.

🏝️ Benefits

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

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