Operating for more than two decades in Greece and Cyprus, CORONIS has been delivering a full spectrum of services to national and international pharmaceutical, biotechnology and medical device industries and other healthcare-related organisations. As a Contract Research Organization (CRO), CORONIS wishes to contribute in the delivery of life-changing therapies to patients worldwide.
Currently we are looking for a Clinical Operation Manager, with experience in delivering interventional cross-functional clinical trials to join our team!
The Clinical Operation Manager is responsible for driving our clinical operation excellence by focusing on project delivery, productivity, and quality for complex, full service clinical studies.
- Operationalize RFP requirements and support the development of business/financial proposals
- Contribute to the development of efficient and innovative study design to support project objectives
- Oversee the execution of clinical projects while optimizing speed, quality and cost of delivery, present project information proactively to all stakeholder
- Set project objectives according to agreed strategy, effectively communicate and assess performance while suggesting ways of improvement
- Ensure resource planning, standard setting, performance management and evaluation
- Collaborate with other operational departments within the company where necessary to support milestone achievement
- Ensure project quality by identifying quality risks, responding to issues raised by project team, and implementing appropriate corrective and preventative action plans
- Direct, lead and motivate the team to ensure a high standard of professionalism, efficiency, effectiveness, and innovation in the delivery of projects
- Ensure compliance with internal processes and regulatory requirements across clinical Services, while contributing to the ongoing update/development and implementation of clinical SOPs
- Identify training needs where necessary, contributing to the design and implementation of education and training to meet the requirements of the projects/Service.
- Manage invoicing process while overseeing service budget. Monitor and reconcile income and expenditure statements while identifying opportunities to accelerate activities and bring revenue forward
- University Degree and Master’s Degree (or Ph.D. or MD) in health or biological sciences, pharmacology, medicine, or chemistry.
- Minimum of 7 years of clinical experience in the Pharmaceutical or CRO including 4 years of demonstrated experience in clinical trials management
- Therapeutic knowledge in at least 2 of the areas: Oncology, Hematology, CNS, Rare Diseases
- Expertise with ICH/GCP and regulatory guidelines pertaining to the conduct of clinical trials on human subjects.
- Solid understanding of the drug development process, pharmaceutical legislation, and scientific matters
- Excellent organizational and prioritization skills and ability to develop, plan and implement short and long-range goals.
- Ability to supervise and train staff, including organizing, prioritizing, and scheduling work assignments.
- Team building, leadership, communication, and mentoring skills.
- Advanced critical thinking and problem-solving skills and ability to take appropriate corrective action.
- Finance and budgeting knowledge.
- Advanced oral and written communication and interpersonal skills (including experience in making presentations at conferences, meetings, and training sessions).
- Excellent command (written and verbal) of English language and proficient knowledge of medical terminology
- IT literacy (MS Windows, MS Office, Internet Use)
- Driving license.
- Availability to travel throughout Greece and abroad (up to 30% of time) with little prior notice.