Lead Data Manager

TN United Kingdom; Oxford; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Lead Data Manager to oversee data management activities in complex clinical studies. This role involves coordinating data collection, cleaning, and reconciliation, while also serving as the primary communication point for project teams and clients. With a focus on quality control and training, this position offers a unique opportunity to advance your career in clinical research. Join a dynamic team where your contributions will drive the success of innovative projects and enhance your professional growth.

Qualifications

• Minimum 3 years of data management experience in international EDC studies.
• Strong organizational and managerial skills.

Responsibilities

• Coordinate data management activities related to EDC development and data cleaning.
• Train Assistant Data Managers and provide project-specific training.

Skills

Data Management

Communication Skills

Organizational Skills

Project Management

Education

College or University Degree

Tools

Medidata Rave

Oracle Inform

Job description

Job Description

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects.

Communication

• Primary communication point for project teams and company departments regarding clinical data management.
• Communication line for clients/vendors for all data management aspects of clinical projects and reporting.

Data Management

• Coordinate data management activities related to EDC development, data collection, cleaning, reconciliation, Database Lock, and final database development.
• Responsible for activities including study document review, developing data management plans, user acceptance testing, validation plans, data entry supervision, data validation, non-CRF electronic data handling, database edits, manual CRF review, database lock, and archiving.
• Contribute to CRF design, develop CRF completion guidelines, and review medical coding and electronic data transfer specifications.

Document Management

• Liaise with Document Center for TMF and eTMF maintenance.

Quality Control

• Perform database QC checks, prepare for audits, and follow up on audit findings.

Training

• Train Assistant Data Managers and provide project-specific training to investigators and clinical teams in CRF completion.

Corporate/Departmental Assignments

• Prepare for and attend investigator meetings and meetings organized by clients/vendors.

Qualifications

• College or university degree or equivalent experience.
• Minimum 3 years of data management experience in international EDC studies.
• At least 2 years using CDM/EDC systems like Medidata Rave or Oracle Inform.
• Project data management experience is a plus.
• Strong organizational and managerial skills.

Additional Information

Advance your career in clinical research and develop new skills while growing with the organization.