Senior Clinical Trial Manager
Remote (USA)
$160,000 - $190,000
A commercial stage biotech is developing innovative treatments for cancers. With a marketed product, 8 clinical drug candidates, and over 40 clinical trials globally, they are able to offer a blend of financial stability along with extensive opportuntiies for growth. They have signed strategic licensing agreements which add to the financial runway and market access for their commercial drug, and have a great leadership team in place.
Responsibilities:
- Read and oversee the planning, initiation, and execution of clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards.
- Effectively manage relationships with investigational sites, fostering collaboration, providing support, and addressing site-specific needs to optimize site performance throughout the trial.
- Implement robust data monitoring processes, conducting regular reviews and source data verification to ensure the accuracy and integrity of data collected in clinical trials.
- Ensure all aspects of clinical trials comply with relevant regulatory requirements and guidelines, collaborating with regulatory affairs to address any compliance-related issues and facilitate successful trial outcomes.
- Proactively identify potential risks associated with Oncology trials and develop strategic plans for risk mitigation. Address and resolve issues promptly to ensure the smooth progression of the trial and meet project timelines
Qualifications:
- Proven track record with a significant duration of experience working specifically in the field of Autoimmunity within the pharmaceutical or biotech industry.
- In-depth knowledge of Oncology and Immunology clinical trials, including protocol design, patient recruitment, and monitoring, with a demonstrated ability to navigate the unique challenges associated with neurological disorders.
- Comprehensive understanding of regulatory requirements and guidelines, ensuring compliance with regulatory standards throughout the drug development process.
- Substantial experience in managing investigational sites, building and maintaining effective relationships, and optimizing site performance to ensure successful trial execution.
- Proficiency in overseeing data review processes, including source data verification and analysis, to ensure the accuracy and integrity of clinical trial data in the autoimmune therapeutic area.
Benefits:
- Medical, dental, vision insurance
- 401(k)
- PTO and Holidays
