Clinical Trial Manager (Neurology)

DUTIES AND RESPONSIBILITIES:

• Implements all aspects outlined in the clinical operational plan including closely tracking study site start up, timelines, enrollment, protocol deviations, regulatory documentation, and trial-related materials such as IP and laboratory sample management.
• Ensure site compliance with the trial protocol, GCP, GMP, and regulatory guidelines.
• Prepare study related documents including initiating and developing clinical trial related SOPs.
• Manage and track established clinical trial budgets.
• Work with Clinical leadership to develop and implement clinical trial contingency plans as needed.
• Communicate regularly with clinical sites and CRO to execute and complete clinical trials and for administrative tracking of study materials.
• Work closely with clinical sites to obtain Institutional Review Board (IRB) approval and any other required approvals needed to execute clinical trials.
• Develop and conduct training for clinical site personnel on the trial protocol.
• Develop process for and track patient enrollment, completion of case report forms, adverse events, and study materials at the clinical sites.
• Represent the Company during the on-site preparation and administration of its cell-based products as necessary.
• Problem-solve issues related to screening, enrollment, and follow up of individual patients.
• Coordinate with the Company’s business development group to execute confidentiality agreements and clinical site contracts.
• Coordinate logistically complex study operations across several vendors and between interacting clinical sites.
• May delegate tasks to clinical operations team members as needed

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a health-related field required with at least 5 years’ experience in clinical research with some experience as a Senior Clinical Trial Associate or higher.
• Experience in operations of neurology clinical trials, experience in Parkinson Disease is strongly preferred.
• Experience in clinical trials utilizing digital health technologies is strongly preferred.
• Experience with clinical trials of cell-based therapeutics, biologics, and/or implanted medical devices, including clinical site support in surgical suites/operating rooms, is strongly preferred.

JOB SPECIFICATIONS:

• Clinical operations knowledge and cross-functional understanding of clinical trial methodology.
• Working knowledge and understanding of ICH-GCP and regulatory guidelines and their implementation in clinical trials.
• Thorough understanding of HIPPA laws and proper handling of patient Protected Health Information (PHI).
• Exceptional organizational skills with the ability to organize and prioritize numerous tasks and complete them under time constraints.
• Collegial personality with the ability to interact effectively with a broad range of organization levels including study coordinators, physicians, and business professionals.
• Ability to present logical solutions to diverse problems proactively before they have an impact on the study.
• Well-developed oral presentation skills and excellent written communication capabilities.
• Ability to understand and communicate biological principles and processes.
• Ability to effectively thrive in a fast-changing small biotech company environment.
• Working knowledge of MS Word, Excel, and PowerPoint is required.
• The candidate must be able to travel nationally approximately 10% to clinical sites.