Company: Docs Global (Continental Europe)
Reference: Ref AS-019739
Closing Date: 07 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
For a globally operating medical device company specialized in orthopedics we are looking for a Senior CRA (m/f) home-based in Germany on a permanent basis. Having started out as a manufacturer for surgical instruments the company specialized in orthopedics supporting surgeons all over the world to provide joint implants to their patients. The company specializes in primary and revision prostheses for larger joints, extremities, fixation, and implants.
Roles & Responsibilities of the position
The main function of a Clinical Research Associate is to manage, support and monitor the conduct of clinical trials and compliance with established timelines.
• Develop and manage designated clinical studies including all phases:
• Protocol study development, investigator/site selection, contract negotiation, preparation of trial related documentation and Ethics committee and/or other required Competent Authorities submissions with follow through to ensure successful outcome;
• Set up the trial sites, train the study staff to trial-specific activities and close trial sites on completion;
• Verify data entered for consistency with original data source, track completed CRFs and timely respond to queries and requests;
• Monitor the trial throughout its duration, which involves both remote monitoring and visiting the trial sites on a regular basis;
• Liaise and communicate with study staff on conducting the trial;
• Maintain and update project files and documentation;
• Analyze data, discuss results and prepare reports/clinical presentations
• Organize and participate in kick-off and investigator meetings to review progress of ongoing clinical trials;
• Review AEs and ensure adequate communication to NCA according to procedures
• Selection and Coordination of the activities with Contract Research Organizations (if involved)
• Liaise and communicate with Marketing and Sales teams and other external parties
• Academic degree in life science (biological science, pharmacy, or other health-related disciplines preferred)
• Minimum of 2-3 years CRA experience in medical devices field
• Knowledge of clinical research principles, ICH-GCP, ISO 14155 and applicable guidelines
• Fluent English and German
• Advanced knowledge in data analysis
• Very good communication and interpersonal skills
• Very good computer skills
• Ability to travel across Europe
Our client offers a position where you can take a lot of responsibility and where you can work truly internationally, covering various clinical trials across Europe. Working in an international company you would have the possibility to develop your career in the field of medical devices.
Interested? Please submit your CV to firstname.lastname@example.org 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, Medical Device, Permanent, Clinical Research, CRA, Clinical Research Associate, Monitor, Monitoring, Clinical Trials, Site Management, Orthopedics, Surgical.
2 Globeside, Globeside Business Park
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