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Lead CRA, Denmark Somerville United States,  

Posted on : 07 May 2017

Project Description

The position as Lead Clinical Research Associate (Lead CRA) offers a unique possibility to take part in the clinical development of Symphogen's antibody products.   As Lead CRA, you will work in close collaboration with the Clinical Trial Manager (CTM) and the Clinical Trial Team in supervising, monitoring, and supporting the administration and pro-gress of clinical trials. When monitoring is performed by a CRO, you will, in collaboration with the Clinical Trial Team and the CTM ensure oversight of contracted resources. You will also be responsible for supporting the CTM in the planning, execution, and reporting of the clini-cal trials. Some travelling must be expected (approximately 10%).   Required Qualifications Education: Minimum Bachelor's Degree in Life Sciences, related field, or equivalent job experience. Advanced degree or certification is preferred. Minimum of 5 years' experience as a CRA in a Pharmaceutical/biotech company or CRO  environment Clinical Trial Documentation/Good Clinical Practice (GCP) experience Functional knowledge of the clinical development process/GCPs/ICH guidelines Understands applicable U.S. Food & Drug Administration (FDA) and European regulations and  requirements Experience in handling, maintaining, and filing clinical documentation for the Trial Master File Effective communication (verbal and written English) and organizational skills Excellent interpersonal skills, proactive, highly meticulous and attentive to detail Able to work independently in a changing environment   Preferred Qualifications Experience in Oncology Experience in writing or reviewing clinical trial plans and documents Experience in training CRO and/or clinical trial site staff Experience from a similar position as Lead CRA   We offer A challenging and versatile job in an innovative, flexible, focused and committed biotech environment Competitive salary based on qualifications Compensation package including a personalized and company-wide bonus system flexible working hours and an inspiring working environment   Working in Symphogen When being a part of Symphogen you will always have a challenging job in a creative, goal-oriented, value-based biotech environment with a meaningful mission. You will be a part of a highly engaged organization with a passion of being the worldwide leading recombinant pol-yclonal antibody company.   You will have good development opportunities, in an organization that is inspiring and grow-ing, with focus on diversity, teamwork, commitment and you as a person.    For further information For more information, you are welcome to contact Ulla Holm Hansen, Senior CTM on +1 908 334 6151 or HR-Director, Lisbet L


Somerville, NJ 08876, USA

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