COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Covance current growth of CoSourse division (CoS) in Hungary brings new opportunities not only for clinical roles, but also another business functions.
CoSource, our insourcing division provides you with the opportunity to work directly for our clients. For these roles you will either work out of our client offices or field based – and see clinical trials from the clients’ perspective. We work in partnership with global and smaller pharmaceutical companies and can support you in your career development.
At the moment we are looking for Start-Up Manager.
Education / Qualifications
- Education in Life Sciences
YOUR MAIN TASKS:
- Delivery of the Global Site Services (GSS) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
- Primary contact with investigative sites during site start-up activities
- Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor
- Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
- Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials
- Where applicable, provide logistical support of clinical trial supply coordination
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 3 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
- Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
- Good organizational and time management skills
- Excellent communication / writing skills
- Strong computer skills with an ability to access and leverage technology alternatives
- Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
- Self-motivation with the ability to work under pressure to meet deadlines
- Works well independently as well as in a team environment
- Detail and process oriented
- Positive attitude and approach
- Multi-tasking capability
- Ability to work independently
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