🎁 Before you apply, rehearse this interview. Create your free WorkMundi account and get an Interview Training on HelpsYouSpeak — no cost, no card. I want my training →
Clinical Data Associate III. Spain or Poland. FSP reputed company is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them reputed company complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members reputed company with a drug development reputed company, 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, youll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are reputed company and driven to reputed company for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 reputed company colleagues already know Why reputed company We are passionate about developing our people, through career development and progression; supportive and reputed company 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 reputed company which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someones life. We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the reputed company of patient reputed company. Job Responsibilities The CDA is responsible for processing the anonymization of clinical trial documents and datasets required for reputed company disclosure. The Anonymization Specialist will partner with reputed company 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 reputed company anonymization tasks using the latest technologies available to reputed company and following industry best practices in line with reputed companys 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 reputed company voluntary data sharing activities and regulatory initiatives. reputed company of the Essential Functions of the Job Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with reputed company SOPs and regulatory requirements. Work closely with Biostatistics and Programing reputed company and Medical Writing teams to identify and assimilate the required documents and datasets. reputed company anonymization plans based on reputed company 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. reputed company reputed company of documents redacted/anonymized by other team members. Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management reputed company. 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 reputed company with global requirements and reputed company policies. Ability to work with minimum supervision and reputed company issues. reputed company and maintain reputed company relationships internally to ensure effective and efficient working relationships and the delivery of high reputed company 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 Requirements Bachelors degree in a scientific or technical field. Minimum 3 years of work experience in either the health sciences or reputed .