Company: CK Clinical
Closing Date: 06 Feb 17
Salary (£): 40,000 - 60,000
Lucy Stendall is recruiting for a Clinical Operations Technical Assistant to join a major blue chip pharmaceutical company in at their site based in Hampshire...
Lucy Stendall is recruiting for a Clinical Operations Technical Assistant to join a major blue chip pharmaceutical company in at their site based in Hampshire on a contract basis for a 12 month rolling contract, working part time for 3 days per week.
The main purpose of the role will be to
- Ensure that essential clinical study documentation within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards.
- Provide administrative oversight and to ensure integrity and compliance to the company's SOPs and regulatory requirements of Investigator Initiated Studies.
- Ensure local clinical operations is effectively supported with respect to system maintenance/ reporting, point of contact for dealing with external submissions/ questions directly or via team where applicable.
- Clinical study document management, including: maintenance of study Trial Master Files, create, track, file and process essential documents and reports, prepare documentation for close out, archive in-house files and third party archiving for sites and arrange for destruction of non-archive materials post study.
- Coordinator and point person for regulatory submissions/ external questions.
- General administration; supporting team members in presentation preparation, Trial Force administrative role/ run periodic TF reports, coordination and set-up of meetings, teleconference agenda, minutes, travel arrangements, couriering/ post duties.
- IIT coordination for country/ cluster when applicable; oversight of the IIT program including coordination with appropriate business partners to insure the IIT program is managed effectively and in compliance with Global and Local policies. Contracting, payment facilitation, issue resolutions and escalations, financial planning/ forecasting and the creation and maintenance of study related documentation.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Good documentation practices
- GCP and TMF knowledge and previous experience
- Some level of knowledge of clinical research activities as well as knowledge of medical terminology
- Excellent computer skills with experience in a variety of software packages
- Excellent teamwork and interpersonal skills as well as excellent problem solving skills.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37928 in all correspondence.
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