Covance Start-up Specialist I in Paris, France
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.
We are currently looking for Study Start-Up Specialist I to join our Start-up team in Covance, Paris.
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
Education / Qualifications
- 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)
Minmum 1 year of work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulation
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
Ability to work independently
Job Number 2018-19131
Job Category Other
Position Type Full-Time
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.