Director of Clinical Operations
Director of Clinical Operations
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Job Description
Summary
Plan drive and oversee all aspects of large multicenter global clinical trials in compliance with GCPs SOPs and program budgets and timelines.
Develop and execute clinical operational strategies for the successful delivery of assigned clinical studies.
Lead Study Management Teams to develop and implement clinical protocols and associated plans.
Collaborate with CRO Study Management Team leads to identify risks implement mitigation strategies and resolve issues proactively.
Oversee highquality execution and delivery of clinical trials within timelines and budgets by managing CROs.
Foster a transparent goaloriented team culture with riskbased oversight.
Manage CROs and vendors including contracting budget oversight and contingency planning for clinical trials.
Ensure compliance with internal policies GCPs and applicable regulations maintaining inspection readiness.
Contribute to the selection qualification and oversight of CROs and vendors.
Support clinical development planning including scenario planning resource estimation and operational strategy development.
Requirements
Bachelor s Degree (Life Sciences preferred); advanced degree highly desirable.
10 years of clinical development and operations experience including leadership roles in global clinical studies and programs.
Proven track record in initiating and delivering large Phase 2 and/or Phase 3 trials.
Experience with respiratory clinical trials preferred.
Strong leadership skills to manage large crossfunctional teams effectively.
Indepth knowledge of global regulatory and compliance requirements including ICH GCP and local country regulations.
Strategic thinker with the ability to balance highlevel objectives with critical details.
Global clinical operations experience across therapeutic areas with a capacity for rapidly learning new indications.
Exceptional written and oral communication skills for effectively conveying ideas and data to diverse stakeholders.
Employment Type
Full Time
