Founded in 1997 by a Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials. Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for complex trials in Rare Diseases, Oncology and Neuroscience.
The Clinical Operations Senior Project Manager (SPM) is responsible for the overall management of all phases of clinical trials utilizing MedSource or sponsor Standard Operating Procedures (SOPs) as applicable, FDA regulations, and ICH-GCP guidelines. The Senior PM possesses in-depth knowledge of and experience in the drug development process, including study start-up, initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation.
The Sr. PM is responsible for day-to-day oversight of all functional area operational activity and impacts to study development, implementation, and maintenance for successful study execution. The SPM will be accountable for multiple projects/sponsors. Accountable for project deliverables meet sponsor’s time, quality, and cost expectations. Work with third party vendors to evaluate study progress, issues, make sound decisions to ensure resolution is achieved. SPM will be accountable for managing project budgets and providing accurate resource allocation forecasting. Manages client relationships and expectations successfully.
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