Clinical Trial Manager
Boston, MA (Hybrid)
$140,000 - $160,000
Job Description
Partnering with a cutting-edge Rare Disease company, EPM is engaged in revolutionizing the landscape of Rare Disease care. This forward-thinking organization, currently in the clinical stage, is dedicated to unraveling the complexities of Rare and Ultra Rare Diseases through groundbreaking research and innovative therapies. With a commitment to pioneering first-in-class treatments, they are shaping the future of 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 Rare Disease innovation and make a lasting impact.
Key Qualifications
- Extensive Rare Disease Experience: Proven track record with a significant duration of experience working specifically in the field of Rare Diseases disorders within the pharmaceutical or biotech industry.
- Clinical Trial Expertise: In-depth knowledge of Rare Disease clinical trials, including protocol design, patient recruitment, and monitoring, with a demonstrated ability to navigate the unique challenges associated with Rare Diseases.
- Regulatory Knowledge: Comprehensive understanding of regulatory requirements and guidelines related to Rare Disease therapies, ensuring compliance with regulatory standards throughout the drug development process.
- Site Management Skills: Substantial experience in managing investigational sites for Rare Disease, 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 Rare Disease 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 Rare Disease 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 Rare Disease clinical trials.
- Regulatory Compliance: Ensure all aspects of Rare Disease 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 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 Insurance
- PTO
- 401(k)
