Associate Director, Clinical Operations - California, United States - Randstad Life Sciences US

Description

Principal Accountabilities

• Supervise the services provided by contracted clinical research organizations, clinical laboratory vendors, and other outsourced partners in order to ensure expectations are met and budgets are within guidelines
• Create, review, and implement clinical study documents (protocols, informed consent forms, clinical study plans, Case Report Forms, etc.).
• Drive IRB/ethics committee and regulatory submissions as needed to meet study timelines.
• Evaluate qualified study sites, oversee site initiation, plan and present at investigator meetings/advisory boards, and implement study start up activities including development of documents related to conduct of the study in collaboration with the clinical study team.
• Lead the set up and management of the Trial Master File (TMF).
• Determine drug requirements for studies, coordinate the distribution of clinical lab samples to central/niche laboratories, and specify shipment logistics to ensure on-time supply for trials.
• Periodically review clinical data, quality metrics and study deviations in order to ensure trial performance measures are being met and the early identification and resolution of issues.
• Manage the deployment of other resources to ensure timelines are met.
• Systematically update Company's senior management on the status of studies to ensure timely problem-solving and to proactively identify and mitigate risks.

Qualifications

• Comprehensive understanding of the overall drug development process typically achieved through a Bachelor's degree in a scientific discipline and 8 years of clinical trial experience in a pharmaceutical, biotech, or a CRO. Advanced degree and multiple years of experience in neurological disorders and/or immunology are differentiators among candidates.
• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations.
• Excellent time management skills with the ability to prioritize deadlines and multitask.
• Self-starter with a demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team.
• Team player with ability to motivate and influence cross-functional team members.
• Ability to handle multiple projects simultaneously, communicate clearly and effectively, and build collaborative relationships.
• Ability to thrive in a fast-paced, entrepreneurial environment, working collaboratively as well as independently, under broad strategic guidance.
• Verbal and written communication skills to the level of effectively producing and delivering compelling and insightful presentations to diverse audiences.