Senior Clinical Trial Manager
New Jersey (Hybrid)
$160,000 - $180,000
Job Description
By using a proprietary drug technology platform they have been able to apply their science into different therapeutic areas. While their clinical pipeline is focused on Oncology now, they're already expanding it into the neurology and immunology space with pre-clinical assets. They have an incredibly robust pipeline with 12 indications across 7 programs, and their lead asset is moving into Phase 3 so it's an exciting time to get in with them. Also, being able to raise upwards of $750 million in funding, they are working on some potentially industry changing developments.
Key Qualifications
- Proven track record with a significant duration of experience working specifically in the field of Oncology within the pharmaceutical or biotech industry.
- In-depth knowledge of Oncology 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 oncology 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 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
- 401K
- Target Bonus
- Dental
