Clinical Data Associate III. Spain or Poland. FSP

Clinical Data Associate III. Spain or Poland. FSPSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job ResponsibilitiesThe CDA is responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure. The Anonymization Specialist will partner with internal and external collaborators on the planning, initiation, and delivery of anonymized documents and datasets in support of the EU Clinical Trial Regulation (EU CTR), ClinicalTrials.gov, and Publications and Regulatory Authority Transparency Submissions (e.g., EMA Policy 0070, Health Canada PRCI), manuscript publications, and data sharing.This individual is accountable to perform anonymization tasks using the latest technologies available to Incyte and following industry best practices in line with Incyte’s principles, policies, standards, and the law. The Anonymization Specialist must demonstrate working knowledge of global transparency regulations and quantitative anonymization tools used for anonymizing datasets and clinical documents to reduce the risk of participant re-identification in support of client voluntary data sharing activities and regulatory initiatives.Summary of the Essential Functions of the JobManage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements.Work closely with Biostatistics and Programing groups and Medical Writing teams to identify and assimilate the required documents and datasets.Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance.Process datasets and documents and apply required transformations.Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA.Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications.Quality check of documents redacted/anonymized by other team members.Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System.Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents.Assist in the development of internal work instructions, training materials, and procedures as needed to comply with global requirements and Incyte policies.Ability to work with minimum supervision and resolve issues.Develop and maintain collaborative relationships internally to ensure effective and efficient working relationships and the delivery of high quality deliverables.Stay informed of new clinical trial disclosure and transparency requirements globally, including but not limited to clinical trial registration and posting of results.Minimum RequirementsBachelor’s degree in a scientific or technical field. Minimum 3 years of work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.).Working knowledge of the global regulatory guidelines pertaining to clinical trial disclosure and transparency.Demonstrated experience in global clinical trial disclosure and transparency processes and systems.Demonstrated Excel and analytical skills, working knowledge of SharePoint and/or document management systems.Strong commun