Clinical Trial Manager
Boston, MA (Hybrid)
$140,000 - $160,000
Job Description
Partnering with a cutting-edge CNS (Central Nervous System) company, EPM is engaged in revolutionizing the landscape of neurological care. This forward-thinking organization, currently in the clinical stage, is dedicated to unraveling the complexities of CNS disorders through groundbreaking research and innovative therapies. With a commitment to pioneering first-in-class treatments, they are shaping the future of neurological healthcare. Join us in a pivotal role where you can contribute to strategies and oversight, ensuring these transformative therapies reach individuals in need. Step into the forefront of CNS innovation and make a lasting impact.
Key Qualifications
- Extensive CNS Experience: Proven track record with a significant duration of experience working specifically in the field of Central Nervous System (CNS) disorders within the pharmaceutical or biotech industry.
- Clinical Trial Expertise: In-depth knowledge of CNS clinical trials, including protocol design, patient recruitment, and monitoring, with a demonstrated ability to navigate the unique challenges associated with neurological disorders.
- Regulatory Knowledge: Comprehensive understanding of regulatory requirements and guidelines related to CNS therapies, ensuring compliance with regulatory standards throughout the drug development process.
- Site Management Skills: Substantial experience in managing investigational sites for CNS trials, building and maintaining effective relationships, and optimizing site performance to ensure successful trial execution.
- Data Quality Assurance: Proficiency in overseeing data review processes specific to CNS trials, including source data verification and analysis, to ensure the accuracy and integrity of clinical trial data in the neurology therapeutic area.
Roles and Responsibilities
- Clinical Trial Oversight: Lead and oversee the planning, initiation, and execution of CNS clinical trials, ensuring adherence to protocols, regulatory requirements, and ethical standards.
- Site Management and Collaboration: Effectively manage relationships with investigational sites, fostering collaboration, providing support, and addressing site-specific needs to optimize site performance throughout the trial.
- Data Monitoring and Analysis: Implement robust data monitoring processes, conducting regular reviews and source data verification to ensure the accuracy and integrity of data collected in CNS clinical trials.
- Regulatory Compliance: Ensure all aspects of CNS clinical trials comply with relevant regulatory requirements and guidelines, collaborating with regulatory affairs to address any compliance-related issues and facilitate successful trial outcomes.
- Risk Management and Issue Resolution: Proactively identify potential risks associated with CNS 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.
