Abdera Therapeutics

Manager

• Serve as primary sponsor contact for assigned clinical sites
• Oversee CRO performance at assigned sites ensuring:
Appropriate site and investigator training
Timely start-up and enrollment
Patient safety and protocol adherence
Conduct oversight for assigned clinical sites including
Review of the site’s Trial Master File for inspection readiness
Review safety data and ensuring timely resolution of outstanding issues
Review of monitoring visit reports, protocol deviations, and site performance metrics.
Proactively identify, prevent, and mitigate site-specific study-related risks
If items are identified that would require re-training the Sr. Manager/Manager will facilitate
Support clinical sites by triaging and resolving operational questions in collaboration with internal teams
Escalate site risks and performance issues to the Head of Clinical Site Management and SVP, as needed
Conduct site visits to strengthen site engagement, improve performance, further ensure adequate oversight of study execution and foster site partnerships
Serve as the direct sponsor contact for assigned sites
Contribute input for site feasibility and future site selection
Participate in departmental initiatives as assigned
Represent Abdera at meetings with investigators/potential investigators and global conferences
Perform other duties as assigned

Sr Manager/Manager, Clinical Site Management - Contract, hybrid or remote