Senior Clinical Data Manager (Remote)

About

This position is 100% remote, with a preference for candidates located on the East Coast. The Senior Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. This role ensures adherence to Standard Operating Procedures/Work Instructions (SOPs/WIs), regulatory directives, and study-specific plans and guidelines. The position also involves overseeing and/or performing database development and testing.

Responsibilities

• Serve as the primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s)/program(s), ensuring back-up, continuity, and responsiveness. May support another Lead DM or serve as a team member. May include DM oversight of sponsor programs.
• Oversee the project data entry process, including developing data entry guidelines, training, and ensuring data entry quality and resourcing.
• May perform quality control of data entry.
• Provide input, assess, and manage timelines, ensuring clinical data management deadlines are met with quality. Assess resource needs for assigned projects as needed.
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
• May assist in building clinical databases.
• Conduct User Acceptance Testing (UAT) for database builds and maintain quality-controlled database build documentation. Oversee the overall quality of the clinical database.
• May specify requirements for all edit check types (e.g., electronic, manual data review, edit checks).
• Oversee the development of edit check specifications and manual data review specifications.
• Create, revise, version, and maintain data management documentation. Oversee the completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on study-specific CRFs, EDC, and other project-related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on guidance from the sponsor and/or Lead DM.
• Run patient and study-level status and metric reporting.
• Perform medical coding of medical terms for consistency and medical logic.
• Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors (e.g., external data and EDC vendors) in a project management capacity to support timelines and data-related deliverables.
• May assist with SAS programming and quality control of SAS programs used in the Data Management department.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and stakeholders.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs).
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
• May attend strategy meetings, bid defense preparation meetings, bid defenses, capability presentations, and potential client engagement meetings.
• May review Request for Proposals (RFPs) and proposals, and provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives, where applicable.
• Train and ensure all data management project team members are sufficiently trained.
• Communicate with study sponsors, vendors, and project teams regarding data, database, or other relevant project issues.
• May present software demonstrations/trainings, department/company training sessions, and present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Requirements

• Bachelor's degree or a combination of related experience.
• 8+ years of experience as a Sr. Clinical Data Manager and 5 years as a Clinical Data Manager II.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Ability to handle a variety of clinical research tasks.
• Excellent organizational and communication skills.
• Professional use of the English language, both written and oral.
• Experience utilizing various clinical database management systems.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Strong representational skills; ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.
• Experience in a clinical, scientific, or healthcare discipline (Preferred).
• Experience with dictionary medical coding (MedDRA and WHODrug) (Preferred).
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) (Preferred).
• Oncology and/or Orphan Drug therapeutic experience (Preferred).

Salary Range: $92,500 - $167,900