Data Compliance Specialist at Thermo Fisher Scientific
Thermo Fisher Scientific · Birmingham, United Kingdom · Onsite
- Junior
- Office in Birmingham
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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
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
Basic MS Office and computer skills
Ability to learn basic medical terminology
Good attention to detail
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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