Stellenbeschreibung

www.daiichi-sankyo.eu Daiichi Sankyo is one of the world's 20 leading pharmaceutical companies and employs almost 32,000 people. The company's world headquarters are in Tokyo. Its European base is located in Munich, Germany. Daiichi Sankyo Europe has affiliates in 12 countries. For our Clinical Operations department in our European headquarters in Munich we are seeking highly qualified candidates to fill the position - limited to 3 years: Clinical Project Associate (m/f) Key responsibilities: Project Management related tasks * Support of the project leader in all aspects of the trial * Review of site contracts together with legal department at the hospital/Investigator and DSE legal department * Support the preparation and design of (e)CRFs * Perform User Acceptance Testing for eCRFs * Support the CRO in preparing and completion of essential documents * Preparation of Monitoring Plans and other trial related documents * Compiling of appendices for Clinical Study Reports (CSR) * Perform QC check of the CSR body including review of tables and listings * Filing of documentation during the trial (electronic and/or hard copy) * Support the archiving of the TMF * Review and update of SOPs * Contribution to the implementation of best practices and standards for trial management, including sharing of ''lessons learned'' CRO oversight * Review of monitoring visit reports including Follow-up letters and continuous control of appropriate follow-up activities * Perform co-monitoring visits at the selected sites including writing of visit reports * Continuous review of protocol deviation listings and follow-up with the CRO * Controlling of TMF set-up and maintenance at the CRO Liaising with sites * Identification of study sites in collaboration with affiliates and/or the CRO * Assessing the suitability of study sites * Liaising with physicians or investigators during the study conduct * Identification of reasons for delayed site or patient recruitment and proposal of appropriate contingency measures Professional experience and personal skills: * University degree in Natural Sciences or an equivalent qualification * At least a minimum of 3 years' working experience in a comparable position in the field of clinical research * Ideally a background in nursing, medical sales or medical practice * Profound knowledge of monitoring and strong project management skills * Familiar with requirements for interventional & non-interventional trials for non-interventional studies within the EU * Strong communication and interpersonal skills, demonstrable intercultural competency * Good negotiation and presentation skills * Strong team player and the ability to build effective working relationships * Professional usage of MS Office applications * Willingness to travel * Excellent organizational and planning skills * Strong German and English skills, both oral and written communication What we offer: We offer an interesting, diversified and challenging position, good contractual conditions, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth. Are you interested in this opportunity? Then we look forward to your online application. Apply online >>