GSS Specialist / Start–Up Specialist
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
Are you ready for the next step in your career?
We are currently recruiting for a GSS Specialist / Start-Up Specialist in Denmark (home-based).
About the job:
- Liaise with operational project team regarding project issues (i.e. participate in team meetings)
- Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
- Liaise with Sponsor and Covance regulatory regarding document submission requirements
- Maintain and update document tracking, site address and contact information in the Site Information
- Assess impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines
- Assess impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly
- Prepare new investigator submission packages to Local and/ or Central IRB /IEC
- Attend ongoing training in GCP, project specific requirements and as may generally be required
- Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying)
- Develop, review and approve drug supply labels as applicable
- Apply basic understanding of data spreadsheets and tables
- Assist with entering data into spreadsheets when required
- Undertake literature and internet searches as required
- Effectively manage multiple projects of varying levels of complexity within agreed turnaround cycles.
- 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.
- 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
- 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