Clinical Trial Project Manager

Position:

Clinical Trial Project Manager

Location:

South San Francisco or Remote

Manager:

Vice President, Clinical Operations & Development

FLSA Status:

Exempt

Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for the clinical translation of scientific research. This is a fantastic opportunity to join a small team, develop and deliver transformative science, and take part in building an exciting, science-driven company.

Key Responsibilities:

·Proactively manage project level operational aspects of the clinical study team, including management of trial timeline, budget, resources, and vendors.

·Provide updates on trial progress to senior/executive leadership with respect to project vendor selection, project plans, project timelines, budget management, quality standards and risk mitigation.

·Participate in the review and negotiation of vendor contracts and budgets.

·Lead sponsor project start up processes, including establishment of Kick-off meetings, the Trial Master File (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.

·Drive project initiation activities, including oversight and management of site contract/budget execution, Institutional Review Board (IRB) approval, and coordination of site trainings, study supplies, and Site Initiation Visits (SIVs).

·Ensure effective project plans are in place and operational for each trial and work proactively with the study team to set priorities.

·Ensure potential clinical trial risks are identified and escalated to senior/executive leadership as appropriate and managed per GCP/ICH6 guidelines.

·Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.

·Monitor the quality of vendor deliverables, address quality issues with the appropriate team members and identify opportunities for training.

·Review and approve vendor invoices in collaboration with Neurona's Accounting team.

·Review and approve vendor responses to audits for appropriateness, timeliness and compliance to company SOPs and regulatory requirements.

·Ensure all project documentation is filed in the TMF and provide oversight to the clinical team regarding document filing, TMF reviews and archival.

·Attend Site Initiation Visits, as needed.

·Conduct monitoring visits, if needed.

·Conduct periodic observation visits of site monitors (e.g. Clinical Research Associates)

·Coordinate and attend, as needed, site trainings (e.g. product training, ancillary device training etc.)

·Oversight and management of Data Safety Monitoring Boards.

·Supervise adverse event reporting, ensure compliance with expedited reporting of Serious Adverse Events

·Supervise clinical trial data accuracy, including SAE reconciliation and query resolution.

·Review and document protocol deviations.

·Review monitoring visit reports.

·Plan and implement corrective actions if needed to ensure protocol compliance.

·Assure the integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records.

·Participate in study data reviews.

Required Qualifications:

·Education: Bachelor's degree in Life Sciences, Nursing Licensure or Pharmacy, at minimum.

·3+ years leading clinical studies in pharmaceutical, biotechnology, medical device or CRO industry.

·Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH Guidelines regarding product development phases, clinical research, and data management methods.

·Therapeutic experience in cell therapy, oncology or medical devices a plus, but not required.

·Experience in early phase trials (Phase I-II) and First-In-Human trials a plus, but not required.

·Strong communication and interpersonal skills (verbal and written).

·Excellent organizational skills; ability to manage multiple priorities.

·Excellent computer skills (Word, Excel, PPT).

·Must be able to work independently and across multi-disciplinary teams.

·Willing and able to travel domestically, anticipated to be < 20% of work time.

Interested in learning more about our science and our team? Please visit our website at www.neuronatherapeutics.com.

For immediate consideration, please apply online via our website: http://www.neuronatherapeutics.com/careers/

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.