Global Clinical Data Lead - Trial Data & DB Ops

Precisionmedicinegroup; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

Precision Medicine Group is seeking a Clinical Data Manager II or Senior to join our global team. Responsible for all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Lead DM activities and oversee database development, QA, and timelines.

The role requires development of CRF specifications, UAT, data QC, and coordination with sponsors, vendors and cross-functional teams. Some travel may be required.

Qualifications

• Bachelor's degree or related experience.
• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ years as a CDM II in CRO/pharma/biotech.
• Set up and database migrations experience.
• Oncology experience preferred.
• Proficiency with Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Excellent organizational and communication skills.
• Professional use of English, written and spoken.
• Experience with various clinical DBMS tools.
• Broad knowledge of drug, device and/or biologic development and data management practices.
• Strong leadership and interpersonal skills.
• Willingness to travel.

Responsibilities

• Lead data management for assigned projects with back-up coverage.
• Oversee data entry guidelines, training, and data quality.
• Perform data entry QC as needed.
• Manage timelines and resource needs for DM activities.
• Develop CRF specifications and coordinate stakeholder feedback.
• Conduct database build UAT and maintain build documentation.
• Specify edit check requirements and data review processes.
• Maintain trial data management documentation and TMF completeness.
• Train staff on CRF/EDC and project items.
• Review data per Data Management Plan and generate line listings.
• Coordinate SAE/AE reconciliation and vendor interactions.
• Assist with SAS programming and QC of SAS programs.
• Present software demos/trainings and participate in project meetings.

Skills

Leadership

Communication skills

English proficiency

Data management knowledge

Clinical DBMS experience

Cross-functional collaboration

Travel flexibility

Education

Bachelor's degree or related experience

Tools

Microsoft Office

Job description

Precision Medicine Group is seeking a Clinical Data Manager II or Senior to join our global team. Responsible for all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Lead DM activities and oversee database development, QA, and timelines.

The role requires development of CRF specifications, UAT, data QC, and coordination with sponsors, vendors and cross-functional teams. Some travel may be required.