Location: Prague, Czech Republic
Closing Date: 16 Mar 17
Salary (£): Competitive
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.
We are currently recruiting GSS Specialists of All Levels in Czech Republic, Prague!
About the Job:
Within this position, your duties will include:
- Overall responsibility for start-up of clinical trials
- Collection and preparation of essential documents
- ICF development as per local legislation
- Clinical trial contracts negotiation
- Regulatory greenlight documents collection and compilation, CTMS, e TMF,
- Cooperation with CRAs
- Contact with investigative sites during site start-up activities
- Working with investigative sites to collect the required investigator and regulatory documents for a study
- 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
- Maintaining site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
- Working 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
- Providing logistical support of clinical trial supply coordination
To be successful in this position, you will need to be educated to 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 have 2 years work Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRBIIEC regulations.
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 3 years work Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB!IEC regulations will be considered.
Additionally, you will need to demonstrate:
- Fluency in English
- 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 I 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
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
THERE IS NO BETTER TIME TO JOIN US!
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
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