About this job
- Market: Life Sciences & Health Care
- Branch: Biotechnology
- Area of Expertise: Clinical
- Location: United States
What is required?
- hours per week: 40
- Education level: Academic Bachelor
- Closing date: Friday, 22 September 2023
About this role: Associate Director Clinical Operations
The Associate Director, Clinical Operations is responsible for overseeing various stages of drug development or multiple complex projects. The successful candidate will play a leading role in establishing and nurturing relationships with investigators, study site staff, CRA’s, and CRO teams. They will closely manage all aspects of Clinical Trial Operations, including project management, study center activities, CRA monitoring, and vendor management, drawing from comprehensive understanding of clinical trial processes.
- Collaborate with cross-functional teams to manage CROs and vendors, escalating issues when necessary.
- Directly supervise contract CRAs, CRO study teams, clinical sites, and vendors for assigned studies, ensuring alignment with company-sponsored studies.
- Oversees study aspect including site feasibility, strategy, selection, enrollment planning, data review, and protocol deviations assessment.
- Develop risk management and remediation plans aligned with project strategies.
- Manage study timelines, provide regular progress updates to senior management, and ensure study finances are within budget.
- Assist in protocol and document development, collaborate with Clinical Supply Management for supply forecasting.
- Create study materials, conduct training, and enhance quality within the functional area.
- Support inspection readiness and maintain filing systems.
- Track essential study metrics and mentor team members.
- Serve as Clinical Operations expert and ensure tasks follow GCP and SOPs.
- Bachelor’s degree in life sciences or healthcare discipline; Master’s degree preferred.
- Minimum 7 years of clinical trial management experience, including 2 years in clinical monitoring within biotech/pharma sector.
- Proficient in GCP, FDA, and ICH regulations.
- Skilled in international clinical trials, managing CROs, and overseeing external service providers.
- Strong grasp of cross-functional areas (data management, regulatory affairs, pharmacovigilance).
- Previous experience mentoring and supervising personnel
- Excellent verbal and written communication abilities, enjoys regular interactions.
- Self- sufficient task, prioritization and independent work capability.
- Willingness to travel, averaging 20%, domestically and internationally.
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
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Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Meagan Geris is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel USA - Minneapolis