Data Compliance Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

TrialMed is a premier global clinical site network, offering comprehensive services for clinical trials from early to late phases (Phase I to Phase IV). As a unified brand, TrialMed consolidates all clinical trial offerings under one global name, ensuring a seamless experience for stakeholders.

• Access to over 250 sites worldwide and a patient database of 20 million individuals, ensuring robust and diverse trial enrollments.
• A patient-centric approach with capabilities for home trial services, allowing patients to participate in clinical trials from their homes or communities.
• Comprehensive service offerings, including early development CRO services, consulting services, and clinical pharmacology services.
  
  

Join TrialMed and be part of a dynamic team dedicated to advancing medical research and improving patient care through innovative clinical

Compliance specialist is an entry role within the clinical data-entry, data validation and discrepancy management. The main objective is to provide high-quality data to ensure that data are complete, reliable, and processed correctly. The main responsibilities are: data collection and data entry to CRF; track the flow of CRFs, queries and patient recruitment status and ability to report out the flow of; data; set up of project files, ensuring sufficiency and accuracy of versions of appropriate documentation; assist with producing guidelines for the data entry process for studies.; Ensure individual development and continual service improvement; be a Data Coordinator on ongoing projects to assist with the delivery of projects within timelines.;Deliver good quality data by ensuring an understanding of source documentation and transcription into CRF; create good relationship with customers and ensure high level of customer service; work according to SOP/COPs and GCP guidelines.; perform quality control as described in the relevant Synexus procedure and as applicable to the role; other duties as assigned e.g. named archives

Key responsibilities for a Data Compliance Coordinator are as follows:

• Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed.
• Assists with data capturing activities on one or more studies. May provide support across multiple sites and/or regions.
• Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries.
• Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations.
• May assist monitors and sponsor representatives with query resolutions after monitoring visits. Escalates to management as needed.
• Learns and adheres to company SOP and COP and assists with input during the review process.
• Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
• Assists with drafting compliance reports.
  
  

Qualifications:

Education and Experience:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
  
  

Knowledge, Skills and Abilities:

• Ability to multi-task and support multiples studies with a number of participants simultaneously
• Good interpersonal skills
• Excellent communication skills with Polish and English
• Basic MS Office and computer skills
• Ability to learn basic medical terminology
• Good attention to detail