Senior Clinical Data Manager - Lead DM & Database Build

Precision Medicine Group; United States; Remote; USD 134.000 - 201.000; Vollzeit

Benefits dieser Stelle

Discretionary bonus

Health insurance

Retirement savings

Life insurance

Parental leave

Paid time off

Zusammenfassung

Precision Medicine Group is seeking a Senior Clinical Data Manager to lead the data management process from study startup to post database lock for assigned projects in the United States. You will serve as the primary DM contact, oversee data entry, QA, CRF specifications, database builds, and UAT, while ensuring timely delivery and data integrity.

The role requires 8+ years in clinical data management, strong English communication, and experience with various database systems.

Qualifikationen

• 8+ years of experience as a Clinical Data Manager
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral
• Experience in 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

Aufgaben

• Lead DM role as primary data management contact for assigned projects
• Oversee data entry process, develop data entry guidelines, and manage quality and resources
• Perform quality control of data entry as needed
• Ensure timelines and resources meet DM deadlines
• Develop CRF specifications from the protocol and coordinate stakeholder feedback
• Assist in building clinical databases and perform database UAT
• Oversee edit check specifications and manual data review processes
• Create and maintain data management documentation and trial master file completeness
• Train clinical research personnel on study CRF, EDC, and related items
• Review and query trial data according to the Data Management Plan
• Run patient and study level status and metric reporting
• Perform medical coding of terms to ensure consistency
• Collaborate with external vendors in a project manager capacity
• Provide leadership for cross-functional and organization-wide initiatives
• Present software demonstrations and department/company trainings
• Travel as required
• Other duties as assigned

Kenntnisse

Leadership

Communication

Organizational skills

English proficiency

Cross-functional collaboration

Ausbildung

Bachelor's degree or higher

Tools

SAS programming

Jobbeschreibung

Precision Medicine Group is seeking a Senior Clinical Data Manager to lead the data management process from study startup to post database lock for assigned projects in the United States. You will serve as the primary DM contact, oversee data entry, QA, CRF specifications, database builds, and UAT, while ensuring timely delivery and data integrity.

The role requires 8+ years in clinical data management, strong English communication, and experience with various database systems.