
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
đĽ 1 minute ago
đŠđŞ Germany â Remote
â° Full Time
đ˘ Junior
đĄ Mid-level
đ§Ş Clinical Research
đť Ghost score 10%
đŁď¸đŠđŞ German Required
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
⢠Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely ⢠Ensure regulatory, ICH-GCP/GPP and protocol compliance ⢠Evaluate site and staff performance and provide site-specific recommendations ⢠Escalate serious issues and develop action plans ⢠Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity ⢠Assess site processes and conduct source document review ⢠Verify clinical data accuracy and completeness in case report forms ⢠Resolve queries remotely and on site and guide site staff ⢠Support clinical study data review and capture using hardware and software ⢠Verify electronic data capture compliance ⢠Perform investigational product inventory, reconciliation, storage, security and dispensing reviews as applicable ⢠Review Investigator Site Files and reconcile them with Trial Master Files ⢠Document monitoring activities and maintain tracking systems ⢠Support subject/patient recruitment, retention and awareness strategies ⢠Manage site-level activities, communications, budgets and timelines for assigned activities ⢠Liaise with study site personnel and ensure assigned sites and project team members are trained and compliant ⢠Attend investigator, sponsor, global monitoring and clinical training meetings ⢠Support audit readiness, audit preparation and follow-up actions ⢠Complete assigned training and maintain knowledge of applicable guidelines, regulations and company SOPs
⢠Bachelorâs degree or RN in a related field or equivalent combination of education, training and experience ⢠Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements ⢠Fluency in German and English ⢠Good computer skills and ability to embrace new technologies ⢠Excellent communication, presentation and interpersonal skills ⢠Located in the Berlin/Leipzig/Dresden area ⢠Ability to manage required travel for monitoring visits
⢠Career development and progression ⢠Supportive and engaged line management ⢠Technical and therapeutic area training ⢠Peer recognition ⢠Total rewards program ⢠Inclusive culture ⢠Reasonable accommodations when appropriate
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