Senior Clinical Data Manager

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

📋 Description

• Oversee and manage all facets of clinical trial data management activities from the initiation of the study to the database lock.

• Ensure the quality and accuracy of deliverables from all data reviewers.

• Collaborate closely with lead data managers on assigned clinical studies.

• Conduct data cleaning and reconciliation activities in accordance with company protocols and study-specific data management documents.

• Handle queries related to assigned clinical studies.

• Create and distribute reports to members of the study team.

• Facilitate external data reconciliation and reconciliation of serious adverse events.

• Review and reconcile laboratory data along with applicable lab normal ranges.

• Assist in the creation and upkeep of data management documentation, including Data Management Plans and eCRF Completion Guidelines.

• Ensure that data management documents are archived in compliance with company SOPs and Work Instructions.

• Assist in the development of eCRF and edit check specifications.

• Collaborate with database builders on the construction of clinical databases and the programming of eCRFs, edit checks, and reports.

• Engage in User Acceptance Testing for clinical database builds, modifications, data transfers, and programmed report outputs.

• Support site and user management within clinical databases.

• Potentially lead Phase I to Phase II studies under managerial oversight.

• Drive data review initiatives and identify as well as escalate potential data issues.

• Work with vendors, including central laboratories, on timelines and data-related deliverables.

• Assist in identifying and resolving operational issues using metrics data, audit reports, and input from the project team.

• Mentor and train study team members on eCRFs and EDC.

• Aid in the development and maintenance of data management SOPs and Work Instructions.

• Perform additional duties as assigned.

⛳️ Requirements

• Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.

• Experience in oncology is preferred.

• Capability to work effectively in cross-functional, team-oriented settings.

• Knowledge of ICH guidelines and the regulatory landscape as it relates to data management.

• Strong understanding of data management processes and the phases of clinical trials.

• Excellent communication skills and the ability to independently resolve issues.

• Robust project management capabilities.

• Outstanding written, verbal, and organizational abilities.

• Strong interpersonal skills and the ability to lead study data reviewers while prioritizing data management tasks.

• Detail-oriented with a focus on accuracy.

• Proficient in computer skills, including Microsoft Office applications.

• Familiarity with at least one EDC system; Medidata Rave is preferred.

• Willingness to travel domestically and internationally as needed.

• Bachelor’s degree or equivalent in a health-related field is preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan for Non-Commercial roles.

• Incentive compensation plan eligibility for Commercial roles.

• Discretionary equity awards.

• Participation in the Voluntary Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account options.

• Life insurance coverage.

• Paid Time Off benefits.

• Wellness program participation.