Lead the planning and execution of RWD collection within EAPs and other non-interventional studies.
Manage communications with clients, physicians, and site staff to ensure effective data collection processes.
Monitor RWD collection and completion, identify data discrepancies or data-quality risks, and coordinate timely follow-up and resolution.
Ensure compliance with ICH-GCP and relevant regulatory guidelines for RWD collection.
Refine and maintain SOPs, templates, and documentation to improve RWD study processes.
Identify opportunities to improve data collection, workflows and supporting tools, and share potential opportunities for additional RWD support with the relevant commercial and client teams.
Collaborate with cross-functional teams (e.g., Clinical Operations, Data Management, and Commercial) to align RWD deliverables with program goals.
What you bring to the table:
Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
2+ years of experience in Data Management, Real-world Data, or Clinical Research.
Familiarity with electronic data capture (EDC) systems and strong proficiency in Microsoft Office Suite.
Strong organizational and problem-solving skills, with great attention to detail.
Understanding of ICH-GCP guidelines (certification preferred).
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