Site Start-up Specialist job. Paris area. Permanent.



COVANCE



If you want to accelerate your Start-up Specialist career think long-term and the possibilities we can offer you:

• We have helped the pharmaceutical industry develop more medicines worldwide than any other company, including thetop 50 best-selling drugson the market today and
• 100 % of all Oncology drugs approvedin 2016.

Explore this job as Start-up Specialist 1 with usand see why Covance has been named among the World\u00B4s Most Innovative Companies in Forbes\u00B4 2017 Ranking, and more than 90% of the top 20 global pharmaceutical companies are repeat customers.



AsCovance is placing a big bet on creating a strong and specialized Start-up Operations team in France, with us you will have realisticInternational Start-up Leadership career progressionopportunities.





THE JOB



This is an office based job in Rueil Malmaison.





You will have full accountability in facilitating the delivery of site start-up activities of your assigned trials. Among your main responsibilities you will:

• Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor,
• Oversee timely collection of investigator and regulatory documents,
• Prepare IRB/IEC submission packages, in accordance with relevant regulations, SOPs, and study specific procedures
• Ensure ongoing accuracy and quality of site/study documents, (e)TMF filing and that systems are updated on an ongoing basis,
• Country and Site Documents customization

WHAT WE\u00B4LL OFFER YOU



As a core member of our team, you will be expected to work autonomously and deliver on project phases on time and on budget. We will help you achieve your goals by continuous professional development, and regular career progression sessions.



This is an exciting position within the Start-Up part of clinical trial where work-life balance is considered:flexi time.



But also importantly:

• Forget the machine-like environment: we are a supportive community where everyone helps each other to succeed, and you will receive direct coaching from our expert managers.
• Your studies will be \u201Cyours\u201D from the beginning until the Amendments stage: you will not jump from study to study without previous notice

Education/Qualifications:
Required:

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 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.


Experience:
Required:

• 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

Locations:
Paris, France