Clinical Operations Director
3 days ago
Mindlance is seeking a highly skilled Clinical Operations Director to join our team. As a key member of our Clinical Development department, you will be responsible for driving the development, optimization, and implementation of clinical trial processes across Kite Clinical Development.
Key Responsibilities:- Develop and maintain clinical trial processes, ensuring compliance with international GCP regulatory requirements.
- Partner with cross-functional teams to develop, optimize, and align shared clinical trial processes.
- Identify and lead process improvement opportunities to enhance efficiency and quality.
- Establish and maintain training curricula for Clinical Operations and support other Clinical Development functions as needed.
- Develop onboarding plans for Clinical Operations and support transition planning within the department.
- Proactively monitor compliance with Clinical Operations procedural documents and training requirements.
- Develop and report process and training compliance metrics.
- Support internal audits and regulatory authority inspections as needed.
- Maintain awareness of industry and regulatory changes to ensure Clinical Development processes are updated as necessary.
- Lead and support efforts to increase compliance awareness and a culture of compliance.
- In-depth knowledge of international GCP regulatory requirements.
- Deep understanding of end-to-end clinical trial processes.
- Organizational awareness and ability to lead cross-functional initiatives.
- Excellent communication skills and ability to negotiate sensitive issues.
- Critical and creative thinking to resolve complex problems.
- Ability to prioritize and adjust workload to meet evolving department and regulatory needs.
- Lead by example to champion quality and compliance.
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
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