Job Name: Clinical Data Manager Job Type: Contract Country: Costa Rica City: Alajuela State: FL Languages: URL: Role Overview: The Clinical Data Manager is a crucial team member, responsible for the management and organization of clinical study data within The Company.This individual works closely under the supervision of the Manager, Clinical Data Management and is instrumental in ensuring that data is entered, validated, and reported in accordance with data management plans and regulatory guidelines.The Clinical Data Manager collaborates extensively with clinical functions and plays a hands-on role in database creation, maintenance, and data validation.The successful candidate will be detail-oriented, efficient, and dedicated to upholding the highest standards of data integrity.Responsibilities: -Assist in the development and implementation of data management plans for clinical trials.-Play an active role in the creation and maintenance of study databases.-Ensure accurate and efficient data entry by study sites.-Assist in the development and implementation of data validation procedures.-Ensure timely reporting of study data KPI's to relevant parties.-Liaise with the study team to guarantee the correct collection and reporting of data.-Address and resolve data-related issues, escalating as necessary.-Ensure adherence to relevant regulatory and guideline standards.-Participate in ongoing training and stay updated on data management procedures.-Review data management documents, providing input as needed.-Contribute to process improvement initiatives.Education: -Bachelor's degree in a relevant field (e.g., statistics, mathematics, computer science, software engineering) with 1-2 years work experience in clinical data management or a related field.-Licenses/ Certifications: Not specified.Experience: -Familiarity with data management software and databases.-Understanding of relevant regulations and guidelines (e.g.FDA, GCP).-Excellent organizational skills.-Attention to detail.-Ability to work collaboratively in a team setting.-Strongly self-motivated -Ability to manage multiple tasks simultaneously.-Able to meet deadlines in a high-pressure environment.Preferred Skills: -Experience with Medidata Rave EDC or Veeva Vault -Exposure to or interest in learning clinical programming languages such as PL/SQL, SAS, C#, R, VB -Exposure to or interest in learning a business intelligence tool such as PowerBI -Familiarity with CDISC, STDM, ADaM would be advantageous Physical Demands: Travel Requirements: - <5% or as needed based on the nature of the clinical trials and projects.
