Hemab Therapeutics is a clinical stage, international biotechnology company that is pursuing a vision of re-imagining blood clotting therapies at the heart of human resilience. Hemab is pioneering the first targeted preventative treatments and functional cures for underserved bleeding and thrombotic disorders—reframing the standard of care for patients everywhere. While patients with common bleeding and thrombotic disorders have had access to preventative treatments for more than a half-century, no such measures exist for less-common disorders. For these tens of thousands of men, women, and children, life is paralyzingly unpredictable. It’s time to ensure that every patient with a clotting disorder has the security and peace of mind they deserve. Our teams are global, diverse and committed to collaboration, excellent research and swift development of our potential therapies.
ABOUT YOUR ROLE
The Senior Clinical Trial Associate provides clinical trial coordination support to the assigned clinical study or studies. This support includes study deliverable tracking and ensuring study documentation including eTMF is maintained for the assigned clinical study(ies). This position will work with internal clinical development team members and with external vendors and CROs. This role may work collaboratively on one program or across several studies to support clinical operations activities.
As a Senior Clinical Trial Associate, you can expect to:
Support clinical study(s) oversight activities from start up to close out
Oversee the CRO’s eTMF for assigned studies
Maintain the internal filing system for ongoing studies
Ensure study management documentation is conducted in accordance with ICH/GCP standards
Coordinate study related team meetings, plan and distribute agenda/meeting minutes as needed
Develop study tracking tools and templates
Track and follow up on action items for clinical deliverables
Assist in developing timelines and study related forecasting
Reconcile and track purchase orders and invoices
Develop and maintain strong, collaborative relationships with multiple cross functional team members as well as with external vendors
Support central lab management and sample management by coordinating and tracking clinical samples through analysis.
Participate in co-monitoring visits as needed, and review study/site level documents.
WHAT YOU’LL BRING
At least 2+ years of study coordination experience in a clinical research environment, with at least some within the biotech/pharma industry
Bachelor’s Degree in a life-science-based subject
Basic understanding of drug development
Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
