Director, Clinical Operations
Arvinas
Google Cloud Platform
Sr Manager/Manager, Clinical Site Management - Contract, hybrid or remote
Abdera Therapeutics
contract
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $155,000 - $175,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
Requirements
- Bachelor’s degree in life sciences is required.
- Minimum of 5 years of relevant clinical research/operations experience required.
- Minimum of 3 year of oncology-solid tumor experience.
- Monitoring experience strongly preferred
- Radiopharmaceutical experience a plus
- Solid knowledge of clinical research regulations (FDA, EMA, HIPAA), Good Clinical Practice (GCP), project management and data handling.
- Willingness to collaborate with team to identify and implement in best practices for optimizing performance
- Skills and expertise in oversight, mentoring and coaching of CRAs
- Detail oriented, organized and committed to quality and consistency
- Excellent communication, interpersonal, and collaboration skills
- Ability to prioritize and manage multiple tasks in a dynamic, fast-paced environment
- Strong organizational, communication and interpersonal skills
- Ability to prioritize and execute to meet project deadlines
- Proficient in Microsoft Office Suite, as well as clinical trial systems such as EDC, IXRS, and CTMS
- Comfortable working in a lean, start-up environment with evolving processes
- Willing and able to travel up to 30%
