Senior Clinical Data Manager

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

📋 Description

• Oversee all facets of the clinical trial data management process from the initiation of the study through to the post-database lock phase for designated projects.

• Adhere to Standard Operating Procedures, Work Instructions, regulatory guidelines, and study-specific plans.

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

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

• Conduct quality checks on data entry as necessary.

• Evaluate and manage timelines, deadlines, and resource requirements.

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

• Assist in the construction of clinical databases.

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

• Ensure quality oversight of clinical databases.

• Specify and supervise edit-checks and manual data review specifications.

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

• Train clinical research personnel on study-specific CRFs, Electronic Data Capture (EDC), and related project materials.

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

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

• Execute medical coding and coordinate Serious Adverse Event (SAE) and Adverse Event (AE) reconciliation.

• Manage external data and EDC vendors to support timelines and data deliverables.

• Provide assistance with SAS programming and ensure quality control of SAS programs.

• Identify and resolve operational issues using metrics, audit reports, and stakeholder feedback.

• Review and give feedback on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) as necessary.

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

• Participate in strategy meetings, bid-defense preparations, capability presentations, and client engagement gatherings.

• Review Requests for Proposals (RFPs), proposals, and furnish project estimates.

• Provide leadership for cross-functional initiatives and organization-wide projects.

• Ensure that data management project team members receive adequate training.

• Communicate effectively with sponsors, vendors, and project teams regarding data, database, and project-related issues.

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

• Travel occasionally as required.

• Perform additional duties as assigned.

⛳️ Requirements

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

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

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

• Capability to manage a variety of clinical research tasks.

• Exceptional organizational and communication skills.

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

• Experience with various clinical database management systems.

• Extensive knowledge of drug, device, and/or biologic development along with effective data management practices.

• Strong representational skills and the ability to communicate effectively, both orally and in writing.

• Excellent leadership and interpersonal abilities.

• Willingness to undertake occasional travel.

• Experience in a clinical, scientific, or healthcare discipline is preferred.

• Familiarity with medical coding (MedDRA and WHODrug) is preferred.

• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) is preferred.

• Experience in Oncology and/or Orphan Drug therapeutic areas is preferred.

• Candidates must have legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.

• Reasonable accommodations for applicants with disabilities.