Senior Clinical Data Manager

We are looking for a Senior Clinical Data Manager to own data management across the full clinical trial lifecycle: study start-up, study conduct, and study close-out. You bring deep, hands-on CDM experience, ramp up quickly, and work independently with minimal oversight while keeping data quality, timelines, and regulatory compliance on track. This is a fully remote position open to candidates based in USA/ Canada.

Key Responsibilities

Study Start-up

• Develop the Data Management Plan (DMP), CRF completion guidelines, data validation specifications, and other study documents.
• Design, build, and test eCRFs and EDC databases, including edit checks and UAT.
• Define data transfer specifications and agreements for external data sources (labs, ePRO/eCOA, IRT, PK).
• Set up coding conventions (MedDRA, WHO Drug) and the data review plan.
• Align with Biostatistics, Clinical Operations, Programming, and Safety on database requirements and timelines.
• Support CRO and vendor kickoff and set up oversight processes.

Study Conduct

• Perform ongoing data cleaning and review, and generate, issue, and resolve queries with sites and cross-functional teams.
• Reconcile external data and serious adverse event (SAE) data against the clinical database.
• Code adverse events, medications, and medical history using MedDRA and WHO Drug.
• Manage database change requests and amendments, including mid-study updates.
• Run data quality checks and metrics reporting, and flag risks and issues early.
• Oversee CRO and vendor data management activities and deliverables.
• Maintain inspection-ready study documentation in the TMF.

Study Close-out

• Lead database lock activities, including final data review, query closure, reconciliation, and coding sign-off.
• Plan and execute interim locks, database freeze, and final lock, including unlock/relock when required.
• Deliver final datasets to Biostatistics and Programming, and support SDTM and CDISC deliverables.
• Archive the database and study documentation, and complete TMF filing.
• Support audits, inspections, and post-lock queries.
• Lead lessons-learned and close-out reviews.

Across All Phases

• Ensure compliance with ICH-GCP, Health Canada, FDA, and EMA requirements, company SOPs, and CDISC standards.
• Mentor junior data managers and contribute to process improvements.

Required Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing, Computer Science, or a related field.
• 8+ years of hands-on clinical data management experience in pharma, biotech, or a CRO, with experience across study start-up, conduct, and close-out.
• Strong working knowledge of at least one major EDC system (e.g., Medidata Rave, Oracle InForm/Clinical One, Veeva CDMS, or similar).
• Solid understanding of the clinical trial lifecycle, ICH-GCP, and data management best practices.
• Proven experience with DMPs, edit checks, data validation, query management, and database lock.
• Familiarity with CDISC standards (CDASH, SDTM) and medical dictionaries (MedDRA, WHO Drug).
• Excellent attention to detail, with strong written and verbal communication skills.
• Ability to work independently, prioritize multiple studies, and meet tight deadlines in a remote setting.

Preferred Qualifications

• Experience across multiple therapeutic areas (e.g., oncology, rare disease, CNS).
• Experience with SAS, R, or data visualization tools such as JReview or Spotfire would be good to have
• Exposure to risk-based quality management (RBQM) and central monitoring.
• Experience managing CRO or vendor relationships.

Core Competencies

Ownership and accountability, problem-solving, quick learner, cross-functional collaboration, and quality-first mindset.