Company: Docs Global (Continental Europe)
Reference: Ref AS-018951
Closing Date: 22 Oct 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Our client is one of the world's leading pharmaceutical companies operating in various therapeutic areas as well as in the field of medical devices. For our client we are currently hiring a Site Manager (Clinical Research Associate) (m/f) home-based in Germany.
Roles & Responsibilities of the position
A Site Manager / Clinical Research Associate 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
• Acts as primary local company contact for assigned sites for specific trials.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs and policies.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• 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
• University degree in Life Sciences, Nursing, or relevant clinical research experience is required. Minimum 1 years of clinical monitoring experience 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.
• Willingness to travel with occasional/regular overnight stay away from home depending on the region.
• Flexible mindset and ability to work at a fast pace within small exploratory study teams
- 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
- And much more!
Interested? Please send a copy of your CV to email@example.com or call us on +49 89 24440 7115 for more details. 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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