Clinical Data Manager

We’re hiring for a “Clinical Data Manager” role in “Aliso Viejo, CA (Onsite)” with one of our industry-leading clients. This is a long-term opportunity, with competitive pay, and the team is actively scheduling interviews.

Role: Clinical Data Manager

Location: Aliso Viejo, CA (Onsite)

Employment Type: W2 Contract

Rate: $45/Hour

Summary:

• The Clinical Data Manager II is responsible for study Data Management activities from study start up to close out.
• Providing input into the data cleaning strategy and leading data cleaning efforts supporting Clinical Studies.
• This individual must possess strong project management and analytical skills and have the ability to review data using various reporting and analytics tools.

Responsibilities:

• Assist with writing, reviewing and management of key documents such as Data Management Plan, Project Plan, CRF completion guidelines, edit check specifications, data review guidelines.
• Manage the User Acceptance Testing (UAT) of clinical databases including EDC.
• Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory.
• Oversee delivery of EDC study deliverables.
• Oversee and support data cleaning efforts and perform regular data review across Glaukos studies
• Perform data review to identify quality issues, data trends/outliers and generate queries as necessary.
• Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management
• Perform review of study SAS and SDTM datasets.
• Provide input and review of clinical data from external sources and assist in data reconciliation.
• Work with programming to produce customized reports or data listings to facilitate data review and cleaning (e.g. safety reviews).
• Generate reports or data listings for study teams as needed.
• Assist medical coding, AE/SAE reconciliation.
• Assist with CDM project documentation including vendor files in an audit- ready manner
• Assist in the monitoring of enrollment information as collected in the database, provide status update to the study team.
• Assist with the preparation of Data Management training materials used for Investigator meetings, in-house personnel and site staff.
• Contribute to the development of departmental processes and procedures.

Requirements:

• 2-5 years of relevant industry experience.
• Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Data Management is required
• Preferred experience in Ophthalmology Therapeutic area.
• In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices
• In-depth knowledge of Data Management Practices and other regulatory guidelines specific to data management Hands-on working knowledge of Electronic Data Capture (EDC) systems (e.g. Inform, RAVE, iMedNet, etc.), database design and database concepts required
• Hands-on ability to review data and ability to use various data review tools
• Project Management experience
• Experience writing Data Management documentation (E.g. DMP, edit check specifications etc.)
• Excellent verbal and written communication skills
• Experience working with CDISC Standards (CDASH, SDTM)
• Experience with SQL, SAS, Excel or other programming language a plus BS or higher in biological science, nursing or other health-related discipline preferred.

Trident Consulting is a premier IT staffing firm providing high-impact workforce solutions to Fortune 500 and mid-market clients. Since 2005, we’ve specialized in sourcing elite technology and engineering talent for contract, direct hire, and managed services roles. Our expertise spans cloud, AI/ML, cybersecurity, and data analytics , supported by a 3M+ candidate database and a 78% fill ratio . With a highly engaged leadership team and a reputation for delivering hard-to-fill, niche talent , we help organizations build agile, high-performing teams that drive innovation and business success. Learn more: .

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