Executive – Regulatory Affairs
Sun Pharma
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Company: Thermo Fisher Scientific
Designation: Associate Patient Data Specialist
Location: Remote, India
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 – enabling 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Works highly independent and performs critical assessments in collaboration with study teams or other departments to determine best approaches to manipulate subject data. The Assoc. Patient Data Specialist is capable of leading active and challenging interdepartmental discussions to explore best strategies and practices after understanding trial specific needs and diverse data bases that can be used as source of information.
Reviews subject data from multiple sources with a data analytic mindset, capable of identifying trends, risks, gaps and areas for optimization as the subject data and the trial develops. Prepares and analyzes clinical trial patient datasets. Adapts to constant changes as trial develops. Capable of providing concise and clear updates to study teams and other key stakeholders after processing and reviewing subject data.
Continually makes efforts to increase knowledge base and professional skills in areas such as programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation / teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles.
The Assoc. Patient Data Specialist generates a thorough understanding of protocol schedule of events (visits, activities and procedures), EDC, Systems, Contracts, budgets and/or payment terms.Â
Escalates performance issues to clinical, site payments and IT managers and may assist with resolution (Follows Escalation Pathway as applicable). Lead internal team meetings and provide updates on subject data statuses. Manage escalations (project team, site and sponsor) regarding tracking system setup/maintenance issues.Â
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Qualifications and Skills (some of the below are desired):
Skills
Remote, India
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