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Role overview

The Clinical Data Manager is responsible for overseeing clinical data management delivery, project documentation, and system rollout activities for EDETEK’s eClinical platform, with the possibility of supporting other platforms as needed. The role combines hands-on clinical data operations with coordination of design, testing, and implementation work. It also plays a key part in maintaining the accuracy, completeness, and overall quality of the final locked clinical database.

This position requires a solid grasp of Good Clinical Data Management practices, related documentation, database structure, and clinical trial context. The role may involve supporting study start-up and closeout activities for both internal and client-specific projects, while ensuring client expectations are translated into effective data management plans and delivered to a high standard.

Key responsibilities

Oversee internal clinical data management efforts and contribute to broader data management initiatives.
Carry out routine and assigned clinical data management tasks across the study lifecycle.
Support project progress by completing responsibilities requested by CPMs and LSCDMs.
Draft case report form structures and related design specifications for forms, reports, and system components.
Help develop and maintain systems that support project infrastructure.
Partner with Clinical Data Specialists to implement and execute data management plans.
Work with clients and sponsors to deliver contracted clinical data management services with strong data quality and integrity.
Perform coding of clinical data using the approved coding dictionaries.
Conduct data cleaning activities and support data quality checks.
Develop and execute testing approaches for system and module validation.
Assist with data transfers, imports, loading, and integration activities.
Complete all documentation required by EDETEK and project-level procedures.
Carry out user acceptance testing for new software and system changes.
Classify clinical events according to the agreed study strategy and plans.
Facilitate database audits, SAE reconciliation, system testing, module testing, and database lock/unlock activities as part of standard clinical data management operations.

Requirements

Strong verbal and written communication skills in English, including the ability to communicate clearly in person and over the phone.
Confidence in leading functional meetings.
High attention to detail and a strong focus on accuracy.
Excellent planning, coordination, and organizational abilities.
Proven capability to manage several projects at once.
Ability to collaborate effectively across different organizational structures and work styles.
Self-driven approach with the discipline to take initiative and meet deadlines.
Comfort working in a team-based, collaborative environment.
Ability to adapt positively in a changing environment.
Strong prioritization and execution skills in a fast-paced, high-pressure setting.
Advanced computer proficiency, including practical use of MS Office and, where relevant, project management tools.
Bachelor’s degree or an equivalent mix of education, training, and experience; a degree in a scientific, medical, or technical field is preferred.
At least 2 years of experience in clinical trials, clinical data management, or a comparable industry training/experience background.
Prior responsibility for the full data management lifecycle is an advantage.
Working knowledge of EDC studies and SAS is required.

Work environment

This is a remote position, and candidates based in the United States or South America may be considered. The role is typically performed in a corporate office setting or remotely, and cross-functional interaction is part of the day-to-day work. Some travel, around 5%, may be required, including possible weekend travel.

Benefits

Choice of comprehensive medical, vision, and dental coverage.
Paid vacation and sick leave.
Annual corporate holidays.
Participation in a 401(k) plan.
Access to a broad range of discounts and perks, including AAA, wholesale, insurance, prescription, fitness, pet, and entertainment programs.
Health Advocate support and an Employee Assistance Program.

Equal opportunity

EDETEK is committed to equal employment opportunity and does not discriminate unlawfully on the basis of race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status, or any other protected status. This commitment applies to all employment terms and conditions, including recruitment, hiring, placement, pay, promotion, discipline, and termination. Reasonable accommodations may be provided for qualified individuals with disabilities where required by law.

Clinical Data Manager