Senior Auditor, Quality Assurance
ICON plc
Google Cloud Platform
Senior Clinical Trial Manager
Adverum Biotechnologies
contract
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $60 - $85 per hour
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Support all phases of clinical research including planning, implementation, completion, and final reports of clinical trials.
- Serve as primary study team contact to manage study start-up, conduct, and close-out.
- Lead cross-functional study execution team to meet project milestones, budgets, and compliance with ICH/GCP and local regulatory authorities.
- Develop, plan, and forecast budget requirements for clinical programs and study sites.
- Manage CRO and vendor evaluation, selection, training, and oversight.
- Facilitate site feasibility and selection processes; conduct sponsor quality monitoring/oversight visits as needed.
- Provide strategic and operational input into study documents (protocol, ICF, CRFs, pharmacy and laboratory manuals).
- Oversight of preparation and submission of safety reports (pharmacovigilance).
- Forecast and manage investigational drug labeling, packaging and distribution; supply chain management.
- Ensure clinical record keeping in preparation for audits and inspections.
- Identify and engage thought leaders, investigators, cooperative groups, and other experts for study design and interpretation.
- In conjunction with data management, assist with eDC development, data listings, issue and query resolution.
- Collaborate on development and set-up of study systems (IVRS/IWRS, site payments and CTMS).
- Develop and report key executional metrics for oversight of clinical trials.
- Assist with creating, reviewing and implementing SOPs and processes in clinical development.
- Ensure documentation is prepared for inclusion in regulatory product submissions.
Requirements
- Bachelor’s degree preferred; Certification in health-related field or Associates degree required. Preference in a health care or scientific discipline.
- At least 5-8 years clinical research experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting.
- Excellent verbal, written communication skills and interpersonal and presentation skills.
- Experience using Microsoft Office (Word, Excel, Power Point); 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; Phase 3 experience is a must.
- 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.
- 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 ophthalmology, gene therapy and/or rare disease indications highly preferred.
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