Company: Docs Global (Continental Europe)
Reference: Ref AS-018509
Closing Date: 25 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
As a driven person who has the ambition to achieve you will be given the opportunity to gain more responsibilities and enhance your professional profile.
Roles & Responsibilities of the position
ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training.
1. Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
2. Acts as primary local company contact for assigned sites for specific trials.
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9. Arranges the appropriate destruction of clinical supplies
10. Ensures site staff complete the data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity and completeness of data collected at trial sites
12. Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents
13. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints.
14. Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF within 5
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. A minimum of 2-3 year of clinical trial monitoring experience is preferred.
Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Good IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the HUNGARIAN country language and English. Good written and oral communication skills.
Working for one of the top pharmaceutical companies within a stable team. Depending on the level of your experience, you will have the possibility to develop your therapeutic are experience and monitoring skills. Competitive remuneration and possibility to develop your career in a dynamic environment with the support of our CTM.
2 Globeside, Globeside Business Park
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