Manager, Clinical Data Management

EDETEK Inc.; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

EDETEK Inc. in the United States is seeking a Manager, Clinical Data Management to lead the clinical data management team, perform data management activities for CONFORM eClinical, and draft design specifications for forms and reports.

The role keeps you hands-on with data operations and project documentation. You will oversee data management projects to ensure quality and timely delivery, identify client needs, develop creative solutions, communicate with clients and internal teams, and

Qualifications

• Understanding of Good Clinical Data Management services and documentation.
• Experience with start-up or wrap-up of data management projects.

Responsibilities

• Support internal clinical data management initiatives
• Complete traditional and assigned data management operations/activities
• Contribute to project success by communicating with clients about requirements and issues, leveraging expertise, enforcing standard operation procedures, monitoring project progress and timelines.
• Assist in the development and maintenance of systems used to support project infrastructure
• Work with Clinical Data Specialists (CDSs) to execute Data Management Plans
• Lead the communication with clients/sponsors as necessary to deliver contracted clinical data management services and clinical data with high quality and integrity
• Ensure filing of all required documentation per EDETEK and project requirements
• Lead Use Acceptance Testing (UAT) on new software

Job description

Manager, Clinical Data Management leads clinical data management team to handle project management documentation, preform clinical data management activities and system implementations for EDETEK’s CONFORM eClinical, write design specifications for the system (forms, reports, etc.), and facilitate testing of system implementations. In addition to stay hands-on with clinical data management operations and activities, Manager of Clinical Data Management oversees data management projects to ensure quality, timely delivery and ongoing client satisfaction; identifies client needs and develops creative solutions for projects, leveraging expertise, operational capabilities and technologies; communicates with clients and internal teams.

The Manager, Clinical Data Management should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.

ESSENTIAL FUNCTIONS

• Support internal clinical data management initiatives
• Complete traditional and assigned data management operations/activities
• Contribute to project success by communicating with clients about requirements and issues, leveraging expertise, enforcing standard operation procedures, monitoring project progress and timelines.
• Assist in the development and maintenance of systems used to support project infrastructure
• Work with Clinical Data Specialists (CDSs) to execute Data Management Plans
• Lead the communication with clients/sponsors as necessary to deliver contracted clinical data management services and clinical data with high quality and integrity
• Ensure filing of all required documentation per EDETEK and project requirements
• Lead Use Acceptance Testing (UAT) on new software