Part-Time Global Site Services (Study Start Up) Specialist
Job Description
COVANCE is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
In Clinical Development Services – our internal Clinical Operations department you will experience the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global clinical trials.
At the moment we are looking for our next Global Site Services (Study Start Up) Specialist, to join our growing operations in Hungary.
As GSS Specialist you will be responsible for all aspects of supporting study start up activities of assigned project within local country or regionally – depending on assignment. If you have at least 6 months of experience in study start up, site feasibility and regulatory submissions – we want to talk to you about our opportunity!
Position: Global Site Services (Study Start Up) Specialist
Location: Budapest, Hungary
System: office based
Responsibilities:
- Primary contact with investigative sites during site start-up activities with responsibility for collection of the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by applicable regulations;
- Maintenance of allocated site’s information in the Site Information Module 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;
- Final review and approval of regulatory documentation for sites managed by another GSS professional (final independent review);
- Where applicable, provide logistical support for clinical trial supply coordination.
Requirements:
- 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);
- 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations;
- Feasibility study and study submissions 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.
We Offer:
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities at an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package
There is no better time to join us!
How to Apply
To apply, please visit our website at careers.covance.com and look for the reference 55028BR. You can also follow the link: http://careers.covance.com/job-postings/55028BR/global-site-services-associate-specialist1782 total views, 0 today