Clinical Data Manager/Senior Clinical Data Manager Job Opportunity

Company: Precision Medicine Group

Job Title: Clinical Data Manager/Senior Clinical Data Manager

Position Summary

The Clinical Data Manager/Senior Clinical Data Manager will be responsible for overseeing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. This role requires adherence to Standard Operating Procedures (SOPs), Work Instructions (WIs), regulatory directives, and study-specific plans and guidelines. The position also encompasses database development and testing responsibilities.

Essential Functions

Key duties include, but are not limited to:

• Acting as the primary Data Management (DM) contact (Lead DM role) for clinical projects/programs, ensuring continuity, responsiveness, and timely task execution. May support another Lead DM and oversee sponsor programs.
• Managing the project data entry process, including guideline development, training, quality assurance, and resource allocation.
• Conducting quality control of data entry as needed.
• Providing input, assessing, and managing timelines to ensure deadlines and quality standards are met.
• Developing CRF specifications from clinical study protocols with stakeholder coordination.
• Assisting in building clinical databases and conducting database build UAT.
• Specifying requirements for all edit check types and overseeing their development.
• Creating and maintaining data management documentation for the Trial Master File.
• Training clinical research personnel on study-specific CRF, EDC, and other project requirements.
• Reviewing and querying clinical trial data according to the Data Management Plan.
• Running patient and study-level status and metric reports.
• Performing medical coding to ensure logic and consistency.
• Coordinating SAE/AE reconciliation.
• Liaising with third-party vendors in support of timelines and data-related deliverables.
• Assisting with SAS programming and quality control.
• Identifying and troubleshooting operational issues based on metrics data and input from project team members.
• Reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs) as needed.
• Participating in the development and maintenance of SOPs and process documentation.
• Attending strategy meetings, bid defense prep meetings, and potential client engagements.
• Providing leadership for cross-functional initiatives where applicable.
• Ensuring all data management project team members receive sufficient training.
• Communicating with study sponsors, vendors, and project teams regarding relevant project issues.
• Presenting software demonstrations, training sessions, and participating in project meetings as needed.
• Occasional travel may be required.
• Performing other duties as assigned.

Qualifications

Minimum Required:

• Bachelor's degree and/or relevant work experience
• 8+ years of experience in clinical data management
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Ability to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Fluency in professional English, both written and oral
• Experience with various clinical database management systems
• Broad knowledge of drug, device, or biologic development and effective data management practices
• Strong leadership and interpersonal skills
• Willingness to undertake occasional travel

Preferred:

• Experience in clinical, scientific, or healthcare disciplines
• Expertise in Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Experience in oncology and/or orphan drug therapeutic areas

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