Senior Clinical Trial Manager
800 Saginaw Drive Redwood City, CA 94063
What You’ ll Do
- Serves as primary study team contact to manage the start-up, conduct and close-out of clinical studies.
- Leads the cross-functional study execution team to ensure that project milestones are met and adhere to approved budgets and are in compliance with ICH/GCP and local Regulatory Authorities’
- Helps with the development, planning and forecasting of budget requirements for the clinical programs and clinical study sites.
- Manages CRO and vendor evaluation, selection, training and oversight
- Facilitates site feasibility/selection processes.
- Conducts Sponsor quality monitoring/oversight visits to sites as needed.
- Provides strategic and operational input into the development of study documents including the study protocol, ICF, CRFs, pharmacy manual, laboratory manual etc.
- Oversight of preparation and submission of safety reports (pharmacovigilance)
- Supply chain management. Forecast and manage investigational drug labeling, packaging and distribution.
- Ensuring clinical record keeping in preparation for audits and inspections.
- Identification and engage of thought leaders, investigators, cooperative groups and other experts regarding latest clinical thinking, study design, study conduct and interpretation of study results.
- In conjunction with data management, assist with EDC development, preparation and/or review of data listings, issue and query resolution.
- Collaborate on the development and set-up of study systems (e.g. IVRS/IWRS, site payments and CTMS).
- Develops and reports key executional metrics for the oversight of the clinical trials.
- Assists with creating, reviewing and implementing SOPs and processes in clinical development.
- Approximately 10-15% travel may be required.
- Bachelor’ s degree preferred. Certification in health-related field or Associates degree required. Preference in a health care or scientific discipline.
- At least 5 years CTM experience in a pharmaceutical, biotechnology setting.
- Excellent verbal, written communication skills and interpersonal and presentation skills are required.
- Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience with email and calendar programs. Experience with IVRS and EDC systems a plus.
- Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools.
- Strong attention to detail and excellent organization skills.
- Strong interpersonal skills and communication skills (both written and oral) able to work effectively in a team/matrix environment.
- Experience in gene therapy and/or rare disease indications preferred