We are partnered with leading privately-owned biopharmaceutical company, in their search for a highly motivated Senior Clinical Trial Manager to play a pivotal role in driving the successful execution of their clinical programs.
Key Responsibilities:
- Provide leadership and guidance to the clinical operations team, ensuring the successful execution of clinical trials.
- Develop and implement strategic plans for clinical trial execution, including site selection, patient recruitment, and data management.
- Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality Assurance, to ensure alignment and adherence to project timelines.
- Oversee vendor selection and management, including CROs and other clinical service providers.
- Monitor and manage the budget and resources allocated to clinical operations.
- Implement best practices in clinical trial management to optimize efficiency and quality.
- Maintain compliance with relevant regulations and industry standards.
- Act as a key point of contact for investigators, study sites, and external partners.
Qualifications:
- Local to Monmouth Junction, NJ and able to come onsite in a hybrid model
- Minimum of 2 years of experience in clinical operations within ADHD or CNS
- Minimum 5 years of direct trial management experience
- Bachelor's degree in a relevant field (advanced degree preferred).
- Strong leadership and team management skills.
- Demonstrated experience in the successful execution of clinical trials.
- Excellent knowledge of GCP (Good Clinical Practice) guidelines and regulatory requirements.
- Proven ability to manage budgets and resources effectively.
- Exceptional communication and interpersonal skills.
- Flexibility and adaptability in a dynamic, fast-paced environment.