Associate Director, Clinical Operations
Research & Development | San Francisco, CA | Full Time
This position will lead the planning, coordinating and execution of one or more global clinical trials in accordance with project milestones, within budget and with high quality in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and Company SOPs. This person will be responsible for leading the study execution for assigned trials, managing and identifying risks and risk mitigation strategies.
Direct clinical operations activities for assigned programs ensuring compliance with Good Clinical Practices (GCP), ICH and applicable regulations
Responsible for the oversight of global studies providing direction and oversight to Clinical Trial Managers and CRO Study Teams. May be the lead for Study Execution to ensure protocol and regulatory compliance
For assigned programs responsible for leading study management, CRO selection, investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports for assigned trials
Develops project timelines, to meet department and corporate goals for timely initiation and completion of clinical studies
Proactively identify study risks and develop and implement mitigation strategies for clinical studies
Oversee and track CRO performance metrics for assigned trials, e.g., site start up, enrollments, data entry, SDV and query resolution
Provide senior management with timely updates on progress and changes in scope and schedule
Coordinate and responsible for oversight of investigator meetings slides and content
Coordinate Site Outreach and enrollment efforts for assigned programs
Partner with and ensure regular and effective communication with key stakeholders including Regulatory Affairs (RA), Biostatistics, Data Management, Clinical Supply, Clinical Science, Legal, Finance, and others, as necessary.
Work with CRO and in-house CTM to develop and revise scope of service agreements
Review investigator contracts and site payments and approval of site and vendor invoices
Collaborate with the study management team and QA to identify potential risks to enrollment, patient safety and data integrity, recommend risk-mitigating strategies and implement and follow through on all corrective and preventive actions till resolution.
Contribute to clinical study reports, sections for Investigator's Brochures, protocols and other regulatory documents
Ensure Clinical Trial Master File for assigned trials are being updated by CRO and are inspection ready
Provide input and may co-lead the development of clinical documents (protocols, clinical trials report, investigator brochures, etc.) and will lead the development of all study related plans necessary for trial conduct.
Self-directed and collaborative while building strong working relationships across multiple departments to finalize documents, including in high-pressure situations
Keeps abreast of current industry practices and standards for outsourcing and GCP system requirements
Demonstrated knowledge of clinical regulatory documentation requirements (familiar with GCP, CTD, FDA, and ICH requirements).
Demonstrate ability to communicate and write clearly, concisely, and effectively with an aptitude for compilation, analysis, and presentation of data.
Excellent writing and editing skills with meticulous attention to detail with solid writing and organizational skills.
Ability to influence without management authority
Able to problem solve and use good judgement
Strong program management and people management skills
Subject to COVID-related conditions and restrictions, must be willing to travel domestically and internationally
Minimum bachelor’s degree in biological science or life sciences discipline. Advanced degree preferred.
At least 10 years' experience in clinical operations with 5 years' experience leading and managing the execution of global clinical trials from start-up through clinical study report generation. Experience in both early and late phase of development preferred.
Preferred Computer Skills:
Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, and PowerPoint and Microsoft Project.