Data Compliance Coordinator
- offer expired 16 days ago
- contract of employment
- manager / supervisor
At AES we are currently looking to attract a Data Compliance Coordinator in our Synexus site in Gdansk.
The Data Compliance Coordinator provides quality control support to the clinical trial process by ensuring all study documentation and source data is accurately captured in CRF and up to date. You will be responsible for maintaining the Investigator Site Files (ISF) as well as performing quality checks and answering any CRF queries in a timely manner.
Coordinates operational compliance activities on one or more studies to ensure successful delivery of the studies
Ensures accurate and timely entry of all data in the CRF from the source notes, and tracks the flow of the CRF’s, queries, and patient recruitment statuses; reports out the flow of data
Maintains ISF and study trackers as delegated
Follows the QC process and checks that ICF’s are correctly completed
Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations
QCs all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flags any out of range values.
Assist with archiving procedures if required
Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits
Identifies quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses
Prepares and collates regulatory documents for submission
Interprets 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.
University education preferably in the field of Life-Sciences or related field
Previous experience or knowledge of clinical trial process and data management, ICH/GCP regulations will be an advantage
Fluent Polish and working knowledge of English
Demonstrated ability to work in a team environment and collaborate with peers
Demonstrated time management skills and ability to adhere to project productivity metrics and time lines
Appropriate MS Office skills
Good organizational, communication, problem solving and planning skills
Able to multi-task and work well within a dynamic environment
What we offer
Interesting and stable job in a multinational company.
Open and friendly organizational culture
Opportunity for development in the clinical research area
Attractive benefit package
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
PPD, now Thermo Fisher’s clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health! Accelerated Enrollment Solutions (AES) is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.