Sr/Clinical Trial Manager
USA (Remote)
$145,000 - $165,000
Job Description
EPM is partnered with a client that is pioneering the Autoimmune space by unraveling the complexities of autoimmune diseases with groundbreaking research and innovative technologies. With a drug already approved by the FDA that generated $120 million in revenue, and 2 drugs entering Phase 1 this year, you will get the stability of being at a revenue generating company, and the growth opportunity of working on an early phase trial. Their commitment extends beyond science, embracing patient advocacy, and fostering collaboration to redefine the landscape of Autoimmune treatments. They are creating a future where every patients journey is met with tailored solutions for their specific condition. By joining this collaborative team, you will help get these treatments to the patients who need them most.
Key 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 Autoimmune 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.
Roles and Responsibilities
- Lead 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 Autoimmune 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.
Benefits
- Competitive compensation
- 401(k), Medical, Dental, Vision
- Performance based bonuses and incentives
