Senior Clinical Data Manager

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

📋 Description

• Manage all elements of the clinical trial data management process from study initiation to post-database lock for designated projects.

• Act as the main Data Management contact and Lead DM for specific clinical projects/programs.

• Supervise project data entry, encompassing guidelines, training, quality assurance, and resource allocation.

• Contribute to and manage timelines, deadlines, quality control, and resource requirements.

• Develop Case Report Form (CRF) specifications based on clinical study protocols and facilitate stakeholder reviews.

• Assist in constructing clinical databases.

• Conduct User Acceptance Testing (UAT) for database builds and maintain quality-controlled documentation for database builds.

• Ensure the quality of clinical databases and oversee edit-check/manual data review specifications.

• Create, revise, version, and uphold data management documentation and the completeness of the Trial Master File.

• Provide training for clinical research staff and data management project team members.

• Review and query clinical trial data in accordance with the Data Management Plan.

• Carry out line-listing data reviews and report on patient/study status and metrics.

• Perform medical coding and manage Serious Adverse Event (SAE) and Adverse Event (AE) reconciliation.

• Collaborate with third-party data and Electronic Data Capture (EDC) vendors to meet timelines and deliverables.

• Assist with SAS programming and ensure quality control of SAS programs.

• Identify and resolve operational issues using metrics, audit reports, and input from stakeholders.

• Review and provide input on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) when necessary.

• Engage in the development and maintenance of SOPs and process documentation.

• Participate in strategy meetings, bid defenses, capability presentations, and client engagement discussions.

• Evaluate RFPs and proposals, providing project estimates.

• Lead cross-functional and organization-wide initiatives.

• Communicate with study sponsors, vendors, and project teams.

• Conduct software demonstrations, training sessions, and project meetings.

• Perform additional duties as assigned.

• May require occasional travel.

⛳️ Requirements

• Bachelor’s degree and/or a combination of relevant experience.

• Over 8 years of experience as a Clinical Data Manager.

• Proficient in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook.

• Capable of managing a variety of clinical research tasks.

• Exceptional organizational and communication abilities.

• Professional proficiency in the English language, both written and spoken.

• Experience with diverse clinical database management systems.

• Comprehensive understanding of drug, device, and/or biologic development alongside effective data management practices.

• Strong representational skills with the ability to communicate effectively both verbally and in writing.

• Excellent leadership and interpersonal skills.

• Willingness to undertake occasional travel.

• Preferred: Experience in a clinical, scientific, or healthcare-related field.

• Preferred: Familiarity with medical coding dictionaries (MedDRA and WHODrug).

• Preferred: Knowledge of CDISC standards (CDASH, SDTM, ADaM, etc.).

• Preferred: Experience in Oncology and/or Orphan Drug therapeutic areas.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance coverage.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.

• Equal Opportunity Employer.