Remote Clinical Data Manager II Lead DM & Database Build

Precision Medicine Group, LLC.; United States; Remote; USD 101,000 - 166,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings plan

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group, LLC. is seeking a Clinical Data Manager II to manage end-to-end data management for clinical trials, including database development, UAT, and data quality oversight.

The role requires 5+ years of CDM experience, proficiency with MS Office and clinical databases, and strong communication skills. Some travel may be required, and SAS programming support is a plus.

Qualifications

• Bachelor's degree or a combination of related experience.
• 5+ years’ Clinical Data Management experience or aptitude in key skills.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills; fluent English.
• Experience with a clinical database management system.
• Broad knowledge of drug, device and/or biologic development and data management practices.
• Willingness to undertake occasional travel.
• Familiarity with CDISC standards (CDASH, SDTM, ADaM).
• Oncology therapeutic experience preferred.

Responsibilities

• Serve as the Lead DM or DM contributor for assigned projects to ensure timely, quality data management.
• May perform data entry for paper-CRF studies and quality control of data entry.
• Contribute to timelines and resource planning for data management activities.
• Develop CRF specifications from study protocol and coordinate stakeholder feedback.
• Assist in building clinical databases and perform UAT on database builds.
• Specify requirements for edit checks and data review processes.
• Maintain data management documentation and Trial Master File records.
• Train study personnel on CRF, EDC, and related items.
• Review trial data per the Data Management Plan and generate line listings.
• Coordinate with vendors and support project timelines and data deliverables.
• May assist with SAS programming and QC of SAS programs.

Skills

Clinical Data Management

Microsoft Office

Communication skills

English fluency

Clinical database management system

CDISC standards

Oncology knowledge

Travel willingness

SAS programming

Education

Bachelor's degree or related experience

Tools

SAS

Job description

Precision Medicine Group, LLC. is seeking a Clinical Data Manager II to manage end-to-end data management for clinical trials, including database development, UAT, and data quality oversight.

The role requires 5+ years of CDM experience, proficiency with MS Office and clinical databases, and strong communication skills. Some travel may be required, and SAS programming support is a plus.