Aspen is seeking a detail-oriented Clinical Trial Manager to join its team. The ideal candidate has neurology experience and is eager to be part of a growing organization. As the primary point of contact with both the clinical sites and the Clinical Research Organization (CRO), this role requires excellent communication skills and study start up experience. This is a hybrid position, with a 3 day in the office expectation (San Diego, CA) for on-site collaboration. At this time, we are not considering fully remote applicants.
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.
- 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.