Syneos Health
Life Sciences
ClinicalDataAssociateIII
“Clinical Data Associate III at Syneos Health. Skills: anonymization, clinical trial disclosure, regulatory guidelines. Process anonymization of clinical trial documents. Process anonymization of clinical trial datasets”
What You'll Achieve.
delivery of anonymized documents and datasets; reduce the risk of participant re-identification; support client voluntary data sharing activities; support regulatory initiatives; delivery of high quality deliverables
Industry & Context.
analytical skills; resolve issues
What They're Looking For.
Must Have
Bachelor’s degree in a scientific or technical field, Minimum 3 years of work experience in either the health sciences or related industries, 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, communication, organizational, time management, and project management skills, Knowledge of ICH-GCP, awareness of clinical publication practices and standards
Nice to Have
Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents, Ability to work with minimum supervision and resolve issues, Develop and maintain collaborative relationships internally, Stay informed of new clinical trial disclosure and transparency requirements globally
What You'll Do.
Process anonymization of clinical trial documents
Process anonymization of clinical trial datasets
Partner with collaborators on anonymization delivery
Perform anonymization tasks using technologies
Manage and facilitate anonymization of datasets
Manage and facilitate anonymization of documents
Work closely with Biostatistics
Work closely with Programing groups
Work closely with Medical Writing teams
Develop anonymization plans
Process datasets and apply transformations
Contribute to Anonymization Reports
Ensure accurate redaction of clinical trial documents
Quality check redacted documents
Collaborate with Regulatory Operations
Assist in development of internal work instructions
Assist in development of training materials
Assist in development of procedures
How You'll Work.
Team & Collaboration
partner with internal and external collaborators; Work closely with Biostatistics and Programing groups and Medical Writing teams; Develop and maintain collaborative relationships internally; Collaborate with Regulatory Operations
Communication Scope
communication skills
Process & Methodology
project management skills
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