RESPONSIBILITIES
• Lead both an internal and external/CRO study management team, to ensure the successful conduct of clinical trials in accordance with state and federal regulations, GCP regulations, ICH guidelines, and internal SOPs
• Manage the supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work
• Author and/or review as needed clinical study documents (protocols, informed consent forms, clinical study plans, Case Report Forms, etc.).
• Drive IRB/ethics committee and regulatory submissions as needed to support study timelines
• Effectively evaluate qualified study sites, perform site initiation, plan and present at investigator meetings/advisory boards, and implement study start up activities including development of documents related to conduct of the study in collaboration with the clinical study team
• Manage and review study and site budgets
• Support the set up and management of the Trial Master File (TMF)
• Assess study drug requirements and shipment logistics; contribute to labeling strategy
• Provide periodic review of clinical data, quality metrics and study deviations
• Review clinical monitoring reports to ensure timely completion and identification of issues
• Manage aspects of the distribution of clinical lab samples to central/niche laboratories used in the study
• Responsible for timelines (from initiation to closure) ensuring they are met
• Communicate study-status and issues to ensure timely decision-making by senior management
• Proactively identifies project risks and resolves with minimal oversight.
QUALIFICATIONS
• Bachelor’s degree in a scientific discipline is required. Advanced degree preferred.
• At least 8 years of clinical trial experience in a pharmaceutical, biotech, or a CRO is required
• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
• Excellent time management skills with the ability to prioritize deadlines and multitask
• Excellent verbal and written communication skills
• Self-starter with a demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team
OTHER KNOWLEDGE AND SKILLS
•Comprehensive understanding of the overall drug development process
•Team player with ability to motivate cross-functional team members
•Excellent ability to prioritize, drive projects forward and resolve conflicts
•Willing to be accountable for team performance
•Experience in neurological disorders and immunology diseases in a plus.
