Clinical Data Manager II

ClinLab Solutions Group; United States; On-site; USD 70,000 - 110,000; Full time

Job summary

ClinLab Solutions Group is seeking a Data Management professional to author and review critical study documents, oversee EDC data deliverables, and lead data cleaning across studies.

The role requires hands-on experience with CDISC standards and EDC systems, strong communication, and cross-functional collaboration to ensure data quality and audit readiness.

Qualifications

• 2 to 5 years of relevant industry experience in Clinical Data Management required.
• Prior experience in Pharmaceutical, Medical Device, Biotechnology, or CRO industry required.
• Experience writing Data Management documentation such as DMPs and edit check specifications required.
• Hands-on experience working with CDISC Standards (CDASH, SDTM) required.

Responsibilities

• Author, review, and manage key study documentation including Data Management Plans, Project Plans, CRF Completion Guidelines, edit check specifications, and data review guidelines.
• Lead User Acceptance Testing (UAT) for clinical databases including EDC systems.
• Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming, and Regulatory teams.
• Oversee and manage delivery of EDC study deliverables against project timelines.
• Support and lead data cleaning efforts, conducting regular data reviews across assigned studies, identifying quality issues, trends, and outliers, and generating queries as needed.
• Represent Data Management in study team meetings, presenting data status metrics and providing guidance on data management issues.
• Perform review of study SAS and SDTM datasets to ensure data integrity and CDISC compliance.
• Provide input on and review of clinical data from external sources, supporting data reconciliation activities.
• Partner with programming to produce customized reports and data listings supporting data review, cleaning, and safety reviews.
• Generate ad hoc reports and data listings for study teams as requested.
• Assist with medical coding and AE/SAE reconciliation activities.
• Maintain CDM project documentation and vendor files in a complete, organized, and audit-ready state.
• Monitor and report on enrollment information collected in the clinical database.
• Assist with the development of Data Management training materials for Investigator meetings, in-house personnel, and site staff.
• Contribute to the ongoing development and improvement of departmental processes and procedures.

Skills

Data Management

Clinical Data

EDC systems

CDISC SDTM

SQL

SAS

Documentation

Quality control

Education

BS or higher in Biological Science/Health science

Tools

Inform

RAVE

iMedNet

Excel

Job description

• Author, review, and manage key study documentation including Data Management Plans, Project Plans, CRF Completion Guidelines, edit check specifications, and data review guidelines.
• Lead User Acceptance Testing (UAT) for clinical databases including EDC systems.
• Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming, and Regulatory teams.
• Oversee and manage delivery of EDC study deliverables against project timelines.
• Support and lead data cleaning efforts, conducting regular data reviews across assigned studies, identifying quality issues, trends, and outliers, and generating queries as needed.
• Represent Data Management in study team meetings, presenting data status metrics and providing guidance on data management issues.
• Perform review of study SAS and SDTM datasets to ensure data integrity and CDISC compliance.
• Provide input on and review of clinical data from external sources, supporting data reconciliation activities.
• Partner with programming to produce customized reports and data listings supporting data review, cleaning, and safety reviews.
• Generate ad hoc reports and data listings for study teams as requested.
• Assist with medical coding and AE/SAE reconciliation activities.
• Maintain CDM project documentation and vendor files in a complete, organized, and audit-ready state.
• Monitor and report on enrollment information collected in the clinical database.
• Assist with the development of Data Management training materials for Investigator meetings, in-house personnel, and site staff.
• Contribute to the ongoing development and improvement of departmental processes and procedures.

QUALIFICATIONS

Experience

• 2 to 5 years of relevant industry experience in Clinical Data Management required.
• Prior experience in the Pharmaceutical, Medical Device, Biotechnology, or CRO industry required.
• Experience in Ophthalmology therapeutic area preferred.
• Experience writing Data Management documentation such as DMPs and edit check specifications required.
• Hands-on experience working with CDISC Standards (CDASH, SDTM) required.
• Experience with SQL, SAS, Excel, or other programming or data analysis tools a plus.

Technical Skills

• In-depth knowledge of FDA/ICH guidelines and industry standard practices for clinical data management.
• Hands-on working knowledge of EDC systems such as Inform, RAVE, iMedNet, or equivalent platforms.
• Proficiency with data review tools and the ability to analyze and interpret complex clinical datasets.
• Working knowledge of CDISC standards including CDASH and SDTM.

Core Competencies

• Excellent verbal and written communication skills with the ability to convey complex data concepts to cross-functional audiences.
• Strong project management and organizational skills with a track record of meeting study timelines.
• High attention to detail and a commitment to data quality and audit readiness.

Education

• BS or higher in Biological Science, Nursing, or a related health science discipline preferred.