Document Coordinator II

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

📋 Description

• Oversee the Sponsor’s Trial Master File during the entirety of clinical trials.

• Assess TMF records for completeness, accuracy, and quality prior to approval.

• Categorize records and assign suitable metadata based on record type and sponsor specifications.

• Detect quality concerns, issue pre-approval inquiries, and facilitate timely resolutions with submitters.

• Engage in or conduct TMF quality reviews and address assigned findings.

• Maintain study milestones and anticipated document lists.

• Assist the TMF Project Lead with monthly TMF metrics and associated reports.

• Participate in internal TMF Focus meetings and provide updates on TMF status, issues, and pending inquiries.

• Work collaboratively with project teams to address challenges impacting TMF records and escalate recurring or unresolved issues.

• Direct TMF activities for Investigator-Initiated Studies and small-scale Sponsored Studies.

• Supervise the eTMF from the initiation of the study through its closeout.

• Create and sustain the TMF Management Plan and TMF Index.

• Compile performance metrics, monitor trends, and produce reports identifying missing records.

• Coordinate TMF activities and deliverables, including regular completeness and quality assessments.

• Lead internal TMF Focus Meetings.

• Manage TMF closeout tasks with cross-functional teams.

• Contribute to process enhancement initiatives and administrative tasks related to computerized systems when assigned.

⛳️ Requirements

• Bachelor's degree.

• Minimum of 1 year experience in clinical research within the biotechnology, pharmaceutical, or CRO sectors.

• Advanced English language proficiency.

• Familiarity with the TMF Reference Model and eTMF technologies.

• Proficient computer skills, including Microsoft Word and Excel.

• Strong organizational skills with the capability to manage multiple assignments.

• Exceptional attention to detail and accuracy.

• Effective communication skills.

• Ability to meet established timelines, expectations, and objectives.

• Flexible and comfortable in a multitasking environment.

• Solid understanding of good clinical practices, as well as relevant Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

• Legally permitted to work in Canada.

🏝️ Benefits

• Flexible work schedule

• Permanent full-time position

• Comprehensive company benefits package, including medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transit discounts, and social activities

• Ongoing learning and development opportunities

• Home-based position