The Clinical Study Manager assumes overall responsibility for the day to day management of clinical trials, ensuring compliance with all regulatory and GCP requirements as well as within budgets and timelines.
- Participate into clinical trial protocols / Case Report Forms (CRFs) development;
- Interact with internal and external customers involved in projects;
- Ensure that clinical trials are conducted in full compliance with Good Clinical Practices (GCPs), internal Standard Operating Procedures (SOPs) and all other requirements (e.g., regulatory) as well as in accordance with study milestones and budgets;
- Collaborate with CTA (Clinical Trial Administrator) and other Clinical Team members to ensure contractual and regulatory documents are properly managed;
- Responsible, with the Medical Affairs Director, for the Medical Devices Vigilance;
- Manage the Clinical Study Supplies (shipment, inventory, destruction, etc.);
- Manage budget, timelines in relation to trials advancement;
- Participate into clinical sites evaluation and selection;
- Oversee patients recruitment;
- Facilitate and participate in audits (internal and/or external);
- Participate in clinical meetings with Investigators;
- Work closely with Clinical Research Associate (CRA) responsible for study monitoring;
- Work closely with CRO
- Collaborate in study results collection, analysis and reporting;
- Other duties as assigned.
- Bachelor's s degree in Health Sciences;
- A minimum of 7 years of clinical experience acquired in pharmaceutical/biotechnology/medical devices companies and/or CMO/CRO settings.
- Knowledge of USA clinical research regulations required
- Knowledge of clinical research methodology, ethical, regulatory, GCP and ICH guidance;
- Budgets management and contract negotiation experience;
- Results-oriented professional with the ability to think strategically and creatively;
- Very strong ability to manage multiple tasks with competing priorities in a demanding, fast-paced and entrepreneurial R&D environment;
- Dedicated self-starter with strong organizational skills and committed to the achievement of objectives;
- Highly developed interpersonal skills with the ability to work equally well independently and in a team environment;
- Good communication skills, confident and articulate;
- Proficient in computer applications and softwares;
- Ability and willingness to travel (approx. 25-30%), as required.