Company: Docs Global (Continental Europe)
Reference: Ref AS-020100
Closing Date: 28 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Our client is one of the world's leading pharmaceutical companies operating in various therapeutic areas (oncology, immunology, cardiology, neurology, virology, metabolics). For our client we are currently hiring a Site Manager (Clinical Research Associate) (m/f) home-based in Germany.
Roles & Responsibilities of the position
This is not one of hundreds of CRA positions. This is a role where you can truly take responsibility and act as a ‘face’ of the sponsor towards the sites.
• You will be responsible for both onsite and remote monitoring of assigned clinical trials.
• You will participate in site feasibility and pre-trial assessment visits, providing recommendation from local area about site/investigator selection.
• You will act as primary local company contact for assigned sites for specific trials.
• You will attend investigator meetings.
• You will be responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out.
• You have to ensure that site staff are trained according to internal training policy and SOPs.
• You will ensure that site study supplies are adequate for trial conduct.
• You will ensure that site staff complete the data entry and resolve queries within expected timelines.
• You will ensure that all AEs/SAEs are reported within the required reporting timelines and documented as appropriate.
• You will maintain all trial documentation in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
• You may participate in the HA and IEC/IRB submission and notification processes.
• University degree in Life Sciences, Nursing, or relevant clinical research experience is required.
• Minimum 2 years of clinical monitoring experience is a must.
• Experience in phase I studies is a must.
• Solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
• Solid communication and computer skills required.
• Proficient in speaking and writing German and English language.
• Friendly work atmosphere
• Variety of therapeutic areas
• Home-based flexibility
• Compensatory time-off
• Travel time = working time
• Contribution to pension scheme
• Company car or car allowance
• Internet allowance
• Ongoing support from your line managers and colleagues
• And much more!
Interested? Please submit your CV to email@example.com. We are looking forward to getting to know you.
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are: Our People, Excellence, Accountability, and Integrity.
Pharma, Pharmaceutical, Permanent, Clinical Research, CRA, Clinical Research Associate, Monitor, Monitoring, Clinical Trials, Site Management, Oncology, Virology, Cardiology, Immunology, CNS, Metabolics.
2 Globeside, Globeside Business Park
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