Play a key role in improving the lives of patients by accelerating the development of our customers' drugs and devices through innovative solutions.
Be a dedicated resource to one of our clients, embedded in their working environment, systems, and processes.
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 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
BA/BS/BSc or RN
Minimum of 4 years of clinical trial experience
Minimum of 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 to effectively work with cross-functional teams.
Knowledge of ICH/GCP and regulatory guidelines/directives.