Company: Docs Global (Continental Europe)
Reference: Ref AS-021193
Closing Date: 31 Mar 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a Clinical Research Associates who are ready to further develop their career and enjoy working for a global organisation in their offices in Sofia.
Roles & Responsibilities of the position
A Site Manager is the person in Trial Co-ordination and Site Management that serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement, training and mentoring of other Site Managers
• 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
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
• Ensures site staff complete the data entry and resolve queries within expected timelines.
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
• A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
• A minimum of 1.5 years of clinical trial monitoring experience is preferred.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills.
What is offered
· Full time permanent employment
· Car allowance
· Work in the unique organization in Bulgaria
Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: email@example.com
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.
Clinical Research Associate, CRA, Monitor, on-site monitoring, Study Conduct, Regulatory, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Warsaw, Poland
2 Globeside, Globeside Business Park
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