Job Description

Senior Clinical Data Manager

The Senior Clinical Data Manager is responsible for study Data Management activities from study start up to close out. The Senior Clinical Data Manager creates the data cleaning strategy and leads the data cleaning efforts supporting Clinical Studies. The Senior Clinical Data Manager works in coordination with Data Management, Biostatistics and Clinical Operations teams to develop standard operating processes in support of clinical research.

Project Management:

• Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management.
• Responsible for study Data Management activities from study start up to close out.
• Author Data Management timelines for assigned studies.
• Manage performance, quality, and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders).

Data Management Documents:

• Author Data Management documentation (e.g. Data Management Plans, Data Review Guidelines and eCRF Completion Guidelines, and Study Timelines, etc.) Author Data Management training materials used for Investigator Meetings, in-house personnel, and site staff.
• Maintain Data Management project documentation including vendor files in an audit-ready manner.
• Assist the Lead Clinical Programmers with the creation and maintenance of Data Transfer Agreements.

Data Review:

• Lead and perform regular data review across Glaukos studies to identify quality issues, data trends/outliers and generate queries as necessary.
• Review and reconcile data from external sources.

Database Build and User Acceptance Testing (UAT):

• Assist with the creation of the CRF and Edit Check Specifications documents.
• Perform User Acceptance Testing (UAT) of clinical databases including EDC.

EDC User Management:

• Manage EDC User Access for all assigned studies.

Collaboration with Cross-Functional Teams:

• Provide ongoing day-to-day support to the Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved.
• Collaborate with internal team and stakeholders to ensure deliverables meet timelines.
• Work with Clinical Programming to produce additional reports outside of the Data Review Guidelines to facilitate efficient data review and cleaning.
• Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory.
• Generate reports or data listings for study teams as needed.
• Review Protocol and provide feedback to the Clinical Study Team on data collection related items.

Process Improvement:

• Participate in the review and update of the Data Management standard operating procedures, work instructions, and templates.
• Participate in the development of departmental processes and procedures.

Minimum of 5 years of experience working in clinical data management, preferably in the pharmaceutical or medical device industry.

Understanding of clinical trial process.

Understanding of FDA/ICH guidelines and industry/technology standard practices.

Understanding of Good Clinical Data Management Practices (GCDMP) and other regulatory guidelines specific to data management.

Hands-on working knowledge of Electronic Data Capture (EDC) systems (e.g. MedNet, Rave, Veeva Vault EDC, etc.).

Hands-on ability to review data and ability to use various reporting and analytics tools.

Multi-tasking, problem-solving and verbal and written communication skills essential.

Project Management experience

Experience writing Data Management documentation (e.g. Data Management Plans, Data Review Guidelines, and eCRF Completion Guidelines, and Study Timelines, etc.)

Excellent verbal and written communication skills.

Ability to work well with others.

Knowledge of CDISC Standards (CDASH, SDTM).

Ability to effectively manage a variety of data management tasks for multiple clinical studies and different stages of activity.

Flexibility in responding to change or business needs.

Proven ability to preemptively identify data and system issues and mitigate risks to data quality.

Bachelor's degree in a relevant scientific or technical discipline.

Desirable

• Familiarity with Ophthalmology Therapeutic area
• Experience with creation of Case Report Forms and Edit Check Specifications.

Job Tags

Similar Jobs