Primary point of contact to lead, manage and coordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP, international regulations and sponsor SOPs
Collaborate with Clinical Program Management teams for global execution of studies
Ensure effective study risk management in place across all areas of studies
Oversee and maintain the quality and scientific integrity of clinical operations for studies at a global level
Collaborate with cross-functional internal and external stakeholders to ensure timely and on budget execution of clinical trial deliverables
Proactively identify and communicate appropriately the status of ongoing studies, identified risks, mitigation strategies, associated action plans and issue resolution measures to ensure timely and on budget execution of study deliverables
Requirements
Education: BA/BS/BSc or RN
Minimum of 4 years of clinical trial experience
2 years of global clinical trial management experience
Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience
Clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Excellent communication and interpersonal skills
Knowledge of ICH/GCP and regulatory guidelines/directives