Senior Clinical Trial Manager
Philadelphia, Pennsylvania Hybrid)
$160,000 - $180,000
Job Description
EPM is partnered with an industry leading biotech focused on creating innovative, novel therapies for traditionally untreated genetic diseases. With leadership that has a track record of raising hundreds of millions of dollars, working at some of the most reputable companies, and getting dozens of drugs approved, this is a chance to get in on the ground floor with a high potential company with extensive room for vertical growth.
Key Qualifications
- Proven track record with a significant duration of experience working specifically in the field of dermatology, gene therapy, or rare disease within the pharmaceutical or biotech industry.
- In-depth knowledge of 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 & 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 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.
Benefits
- Medical, dental, vision insurance
- 401(k)
- PTO and Holidays
