Clinical Data Manager

1w1 week ago

Celerion

Lincoln, US · Full-time · $70,000 – $95,000

About this role

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. The Clinical Data Manager is responsible for the integrity of data entered into Celerion or Sponsor provided systems.

Ensures database is complete, accurate, consistent, and meets quality standards required by Sponsors and regulatory bodies. Manages, organizes, and processes clinical data using a range of computer applications and database systems. Facilitates collection and cleaning of subject data across studies.

Collaborates and participates in multidisciplinary teams involved in setting up, conducting, and reporting clinical trials. Serves as primary Sponsor contact for data management processes. Handles project communication and timeline management for all data functions with regular updates to internal and external teams.

Proactively assesses project activities to identify issues and risks. Provides high level customer service to all internal and external clients. Ensures on-time delivery of study deliverables through monitoring of timeline commitments.

Requirements

High School Diploma or GED, College degree strongly preferred
1-2 years industry experience preferred
Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part 11 preferred
Knowledge of SAS preferred
Ability to manage multiple projects/priorities required
High attention to detail required
Excellent oral and written communication skills required
Excellent organizational skills required
Proficiency in MS Office applications required

Responsibilities

Provide oversight of all clinical data management activities for assigned studies in accordance with SOP’s and Procedure Guides
Act as primary Sponsor contact for data management processes on study
Maintain regular communication of study progress with internal and external project team
Oversee CRFs from creation of the blank CRF through delivery of final CRF to sponsor
Ensure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical database
Coordinate creation of Data Management Plan, CRF Completion Guidelines, Data Validation Plan, and other study documents
Manage clinical data cleaning and delivery activities up to and including database lock
Review clinical data to ensure accuracy, quality, and integrity; generate, resolve, and track queries

Benefits

Guided by Celerion Values: Integrity, Trust, Teamwork, Respect
Equal Opportunity Employer
Consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability