Data Compliance Specialist (On-site)
Pharmaceutical Product Development (PPD)
Sofia, Bulgaria
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Alongside clinical research through our PPD® clinical research portfolio, our work in Accelerated Enrollment Solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.
We are currently looking to recruit a Data Compliance Specialist for our Synexus Clinical Research site in Sofia, Bulgaria.
Working on-site, you will provide quality control to the clinical trial process by ensuring all study documentation and source data is accurate and up to date, maintaining the Investigator Site Files (ISF) as well as performing quality compliance checks and answering any CRF queries in a timely manner.
Key responsibilities for a Data Compliance Specialist are as follows:
- Acts as a core study compliance lead on several studies to ensure the successful delivery of projects.
- Participates in the start-up, set-up and close out of studies, ensuring adherence to the clients expectations.
- 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 status and report out the flow of data.
- Ensures protocol visit windows are scheduled according to the protocol requirements and reports deviations.
- Maintains ISF and study trackers as delegated.
- Assists with archiving procedures, if required.
- Frequently liaises with monitors and client representatives, and completes the preparation for monitoring visit duties and audits.
- Identifies quality issues (QI) and reports on it, and supports and mentors junior compliance coordinators in this process.
- Reviews informed consent forms for completion and escalates concerns.
- Ensures adherence to rules and regulations of ICH. GCP and other regulatory and ethical guidelines. as well as data protection regulations.
- Reports any non-compliance of service level agreements.
- Highlights any auditor findings and proposes CAPA actions.
- Responsible for audit preparation and ensures audit readiness of site files.
- Identifies trends in data queries.
To be considered for this exciting opportunity you will require the following skills and experience:
- 1 year experience in clinical trials will be seen as an advantage.
- Life-science degree will be an advantage.
- Good working knowledge of business English.
- Good multitasking and project management skills in order to oversee multiple studies simultaneously.
- Well-developed interpersonal and communication skills, the ability to work in a cross functional team.
- 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.
Job posted: 2024-03-05
