Senior CRA - Phase I oncology trials - Hamburg/Berlin region

Senior CRA – Phase I Oncology Trials – Hamburg/Berlin Region Syneos Health is a leading life sciences services organization. We partner with innovators across the drug development continuum, helping them navigate complexity and accelerate progress. Location: Hamburg/Berlin region. Job Responsibilities Perform site qualification, initiation, interim monitoring, site management and close‑out visits (on‑site or remotely), ensuring compliance with ICH/GCP, GPP and protocol. Conduct full source data verification and data review of medical records and CRFs, resolve queries and drive closure within agreed timelines. Verify investigational product accountability, inventory and correct dispensing per protocol and regulatory requirements. Evaluate site performance, provide recommendations, communicate and escalated serious issues to the project team, and develop action plans. Maintain knowledge of ICH/GCP guidelines, local regulations and company SOPs; verify informed consent procedures and protect patient confidentiality. Prepare and document all activities via letters, reports and logs as per SOPs and the Clinical Monitoring Plan. Support subject recruitment, retention and awareness strategies; track all observations and action items in tracking systems. Manage site‑level activities, communicate with site staff, train and mentor junior CRAs, and provide audit‑readiness support. Attend investigator or sponsor meetings and support global monitoring project team meetings. Perform required travel of up to 75% of time. Qualifications Bachelor's degree or RN in a related field or equivalent education, training and experience. Knowledge of Good Clinical Practice, ICH guidelines, and other applicable regulatory requirements. Experience as CRA with a strong background in oncology clinical trials across all phases, including early‑phase/first‑in‑human studies, safety, PK/PD and dose‑escalation designs. Good computer skills and ability to embrace new technologies. Hands‑on experience supporting solid‑tumor indications such as melanoma, breast, ovarian, prostate and lung cancer; comfortable in fast‑paced development environments. Prior exposure to investigational products involving Toll‑Like Receptor pathways, PARP1 inhibitors or Werner helicase protein is desirable but not required. Excellent communication, presentation and interpersonal skills; basic critical‑thinking skills expected. Multilingual capabilities, particularly fluency in English with French, German and/or Flemish, are strongly preferred. Ability to manage required travel of up to 75% on a regular basis. The Company is committed to compliance with the Americans with Disabilities Act and the EU Equality Directive. Reasonable accommodations are provided where appropriate. For more information: #J-18808-Ljbffr Syneos Health Germany GMBH