Sr. Clinical Research Associate (Germany)

Kurz zusammengefasst

Alimentiv is a global contract research organisation dedicated to developing therapies for gastrointestinal diseases. With a 30‑year track record, the company supports the majority of IBD drug programmes and operates as a profit‑with‑purpose business that reinvests earnings into research, technology and its people. The role advertised is Senior Clinical Research Associate, based in Germany, responsible for overseeing the full lifecycle of clinical trial sites across the country. In day‑to‑day work the Senior CRA will independently conduct both onsite and remote monitoring visits, covering site qualification, initiation, routine monitoring and close‑out. They will act as the main liaison for each assigned investigative site, handling queries, resolving protocol deviations and ensuring that all activities adhere to the study protocol, ICH‑GCP, local regulations and internal SOPs. The position also involves reviewing source data and electronic trial records for accuracy and completeness, supporting site selection and activation, and driving patient recruitment to meet milestones. Documentation oversight includes maintaining the Investigator Site File and electronic Trial Master File, while collaborating with sponsors, project managers, vendors and other cross‑functional teams to keep studies on schedule. Participation in audits, inspections, investigator meetings and internal process‑improvement initiatives is also expected, as is mentoring junior CRA I and II staff through co‑monitoring and assessment activities. The must‑have qualifications include a bachelor's degree with honours in a life‑science‑related field, with a master's degree being preferred. Candidates need between four and six years of relevant clinical research experience, though seven to nine years is ideal, and must have solid site‑monitoring experience from start‑up through close‑out. A thorough understanding of ICH‑GCP, clinical research principles and German regulatory requirements is required, as is proficiency with trial systems such as EDC, IRT, eTMF and CTMS, with specific experience in Medidata Rave or Oracle InForm considered advantageous. Strong communication, organisational and problem‑solving abilities, a high attention to detail, and the capacity to work independently while managing competing priorities are essential. Fluency in written and spoken English and a valid driver's licence are also mandatory, together with a willingness to travel 40‑60 % of the time. Preferred, but not essential, attributes include experience with Phase I‑IV trials, prior mentoring of junior CRAs, and familiarity with Microsoft Office. The role offers the chance to work within a dynamic, multi‑national team, contributing to high‑impact studies that aim to improve patient outcomes in gastroenterology. What the role asks for: - Bachelor's degree (Honours) in Life Sciences or related field - 4–6 years clinical research experience - Strong site monitoring from start‑up to close‑out - Knowledge of ICH‑GCP and local regulations - Proficiency with EDC, IRT, eTMF, CTMS systems - Experience with Medidata Rave or Oracle InForm preferred - Fluent written and verbal English - Valid driver's licence - Willingness to travel 40–60 % of time - Nice‑to‑have: Master's degree - Nice‑to‑have: Experience mentoring junior CRAs - Nice‑to‑have: Phase I, IV trial experience.