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Job Details

Global Site Services Associate (GSS Associate) in Brussels

Company: Covance
Location: Belgium
Reference: 68931BR
Closing Date: 02 Sep 17
Type: Permanent
Salary (£): Competitive

Job Summary:

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.


We are recruiting for our Clinical Research Team in Brussels and are currently seeking to hire a Associate, Global Site Services to help support the team with investigative sites, CRAs and Ethics committees (EC) and you will be assisting for site start up and site maintenance.

This is a permanent, full time position, based in our office in Brussels.

About the job:

Within this position, your duties will include:

- Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan
- Assist in review and approval of regulatory & investigator documents for study site activation and drug shipment trigger
- Assist in preparation of project specific plans for the GSS component of assigned studies
- Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable
- Assist in reviewof core Country patient informed consents for compliance to country requirements and protocol as applicable
- Assist in review of investigative site specific patient infonned consents for required elements
- Maintain and update document tracking information in the Trial Tracker™ Site Infonnation Module and other tracking logs
- Assess impact of site persom1el changes on regulatory documents and process/review new documents according to GCP/ICH guidelines
- Assess inipact of study amendments on Informed Consent and other study documents and revise and review accordingly
- Liaise with applicable!RB/IEC regarding investigator submission/approval issues as appropriate
- Setup and maintain investigative site files
- Understand and follow project specific and GSS policies and procedures
- Generate investigative site status reports for supervisor review
- Assemble administrative binders for study sites
- Perform other duties as assigned by management
- Assist in managing the drug snpply vendor activities as applicable
- Assist in developing, review and approval drug supply labels as applicable
- Assist with the preparation and dissemination of feasibility documents according to the processes in place
- Assume responsibility for identifying key therapeutic area investigators and consultants for external feasibility
- Develop and populate response spreadsheets from returned surveys; tabulate data into summary tables for incorporation into formal feasibility survey reports
- Assume responsibility for contacting and following with investigator sites regarding completion of confidentiality agreements and other information that may be required
- Design and generate standard and complex query reports from various databases to support internal/client requests for information; develop and/or review time/cost reports for feasibility activities
- Responsible for identifying internal resources, locating critical historical data contained in feasibility and proposal archives, prioritizing requests for information from various internal databases and determining appropriate format for reporting same

About you:

To be successful in this position, you will need to be educated to a 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)

In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years work experience in clinical research, including a strong working knowledge of the !CH guidelines and FDA, IRBIJEC regulations will be considered

And also:

- Good organizational and time management skills
- Working knowledge ofICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred
- Good communication skills, oral and written
- 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
- Interact with internal and external customers with high degree of professionalism and discretion
- Multi-tasking capability
- Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training, capable of operating standard office equipment (e.g. fax, copier etc.).
- Flexible and adaptable to a developing work environment

We offer:

The opportunity to work within an Experience d and highly skilled team.
Covance offers a comprehensive benefits package including health cover and a contributory pension.

Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
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!

Apply for this job: Global Site Services Associate (GSS Associate) in Brussels

Contact Information:

Address:  Covance- Brussels

Website:  Visit Our Web Site

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