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.

• Create project documentation along with procedures and processes for data entry and validation.

• Take charge of all data management activities while adhering to timelines and budget constraints.

• Act as a subject matter expert during meetings with sponsors.

• Comprehend sponsor requirements and lead their execution effectively.

• Evaluate client-specific processes and drive enhancements.

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

• Function as Study Manager, accountable for data management deliverables and the output of the study team.

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

• Lead internal meetings focused on data and align deliverables with EDC Design, SAS Programming, Statistics, and PK.

• Identify risks and mitigations, communicating data-driven discussions to meet database lock deadlines.

• Manage the receipt and inventory of clinical and vendor data, completing all project documentation.

• Cultivate and maintain client relationships, review satisfaction surveys, and implement necessary action plans.

• Monitor scope changes and secure sponsor approvals.

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

• Acquire knowledge of new data management technologies and foster process enhancements.

• Ensure that services and quality align with DMP and scope-of-work specifications.

• Draft, review, and revise SOPs and related documents.

• Keep accurate 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.

• Attend to and resolve client or internal audit issues.

• Support strategic direction and advocate for Biometrics services to sponsors.

• Perform additional duties as required.

⛳️ Requirements

• University or college degree.

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

• Relevant and equivalent experience may be considered in place of educational requirements.

• Proficiency in spoken, written, and reading English is essential.

• 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.

• Demonstrated experience in managing customer negotiations.

• Experience overseeing Scope of Work and budgets.

• Background in oncology is preferred.

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

• Ability to lead project strategies and fulfill departmental goals, objectives, and initiatives.

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

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

• Capacity to work collaboratively within a team environment with peers.

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

• Experience representing data management in bid defense meetings.

• Excellent organizational, communication, and interpersonal skills.

• A constructive problem-solving approach while focusing on deadlines.

• Preferred: a 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.

🏝️ Benefits

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Life insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(K).

• Paid time off (PTO) or Flexible time off (FTO).

• Company bonus where applicable.

• Comprehensive benefits for regular full-time or part-time employees working 20 or more hours per week.