Clinical Data Manager II - Contract

Position: Clinical Data Manager II, Req# 572744

Location: Aliso Viejo, CA (100% Remote)
Duration: 6+ monthcontract with the possibility of extension

Job Description:

The Clinical Data Manager II is responsible for managing clinical data management activities from study start-up through closeout. This role involves contributing to data-cleaning strategies and leading data-cleaning efforts to support clinical studies. The ideal candidate will possess strong project management and analytical skills, along with the ability to review clinical data using various reporting and analytics tools.

Education and Experience: 

• Bachelor's degree or higher in Biological Sciences, Nursing, a health-related discipline, or a related field is preferred.
• 2–5 years of relevant industry experience in Clinical Data Management.
• Experience working in the pharmaceutical, medical device, biotechnology, or Contract Research Organization (CRO) industry.
• Experience in the ophthalmology therapeutic area is preferred.
• In-depth knowledge of FDA and ICH guidelines, industry standards, and technology best practices.
• Strong understanding of clinical data management practices and applicable regulatory guidelines.
• Hands-on experience with Electronic Data Capture (EDC) systems, such as InForm, Medidata Rave, or iMedNet.
• Knowledge of clinical database design and database concepts.
• Practical experience reviewing clinical data using various data review and analytics tools.
• Project management experience and the ability to coordinate cross-functional activities.
• Experience preparing clinical data management documentation, including DMPs and edit check specifications.
• Experience working with CDISC standards, including CDASH and SDTM.
• Excellent verbal and written communication skills.
• Experience with SQL, SAS, Microsoft Excel, or other programming languages is an added advantage.

Key Responsibilities: 

• Assist in the preparation, review, and management of key documents, including Data Management Plans (DMPs), project plans, CRF completion guidelines, edit check specifications, and data review guidelines.
• Manage User Acceptance Testing (UAT) of clinical databases, including Electronic Data Capture (EDC) systems.
• Facilitate cross-functional data management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming, and Regulatory teams.
• Oversee the delivery of EDC-related study deliverables.
• Oversee and support data-cleaning activities and conduct regular data reviews across clinical studies.
• Identify data quality issues, trends, and outliers, and generate queries as necessary.
• Represent Data Management in study team meetings by providing data status metrics and guidance on data management-related issues.
• Review study SAS and SDTM datasets.
• Review clinical data received from external sources and assist with data reconciliation.
• Collaborate with programming teams to develop customized reports and data listings to facilitate data review and cleaning, including safety reviews.
• Generate reports and data listings for study teams as required.
• Assist with medical coding and adverse event (AE) and serious adverse event (SAE) reconciliation.
• Maintain clinical data management project documentation, including vendor files, in an audit-ready manner.
• Monitor enrollment information captured in clinical databases and provide regular status updates to study teams.
• Assist in preparing data management training materials for investigator meetings, internal personnel, and clinical site staff.
• Contribute to the development and improvement of departmental processes and standard operating procedures.