Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development. We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there. If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you! Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development. We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there. If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you! Job Overview As a Senior Clinical Research Associate, you will play a key role in the successful delivery of clinical trials by independently managing clinical site monitoring and site management activities across Germany, from study start-up through close-out. You will act as a primary point of contact for investigative sites in these countries, ensuring compliance with protocols, ICH-GCP, applicable regulations and study requirements while supporting high-quality patient data and study delivery. This is a senior individual contributor role with responsibility for supporting site performance, resolving issues, maintaining study documentation and providing guidance and mentorship to junior CRAs. You will work closely with Clinical Operations, Project Management, sponsors and other cross-functional teams in a dynamic clinical research environment. Key Responsibilities: Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Germany. Ensure investigative sites comply with study protocols, ICH-GCP, applicable regulations, SOPs and project-specific requirements. Serve as a primary point of contact for assigned sites, managing site-related questions, issues, action items and protocol deviations through to resolution. Review clinical trial data, source documentation and study systems to ensure accuracy, completeness, data integrity and compliance. Support site selection, activation and recruitment activities, working with sites to achieve study milestones and patient recruitment targets. Ensure sites are appropriately trained on protocols, study systems, processes and applicable requirements throughout the study lifecycle. Maintain oversight of essential study documentation, including ISF and TMF, ensuring documents are complete, accurate and filed in a timely manner. Collaborate with sponsors, project teams, vendors and investigative sites to support study timelines, resolve issues and maintain effective working relationships. Participate in audits and inspections, Investigator Meetings, study meetings and other project activities as required. Provide mentoring and support to CRA I and II colleagues, participate in co-monitoring and CRA assessment activities, and contribute to process improvement initiatives. Skills & Qualifications Bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline; a Master’s degree is preferred. 4–6 years of relevant clinical research experience, with 7–9 years preferred. Strong clinical site monitoring experience across clinical trial activities from site start-up through close-out. Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements. Experience with Phase I–IV clinical trials preferred. Proficiency with clinical trial systems such as EDC, IRT, eTMF, CTMS and Microsoft Office, with experience in systems such as Medidata Rave or Oracle InForm preferred. Strong understanding of site management, including site activation, recruitment, training, issue resolution and maintenance of essential documentation. Excellent communication, interpersonal and relationship-management skills, with the ability to work effectively with investigative sites, sponsors and cross-functional teams. Strong organisational, problem-solving and prioritisation skills, with a high level of attention to detail and a sense of urgency. Ability to work independently, demonstrate sound judgement and manage competing priorities in a results-driven environment. Experience mentoring or supporting junior CRAs is preferred. Willingness and ability to travel approximately 40–60%, depending on project requirements and geographic location. Valid driver’s licence required. Fluent written and verbal English. Job Overview As a Senior Clinical Research Associate, you will play a key role in the successful delivery of clinical trials by independently managing clinical site monitoring and site management activities across Germany, from study start-up through close-out. You will act as a primary point of contact for investigative sites in these countries, ensuring compliance with protocols, ICH-GCP, applicable regulations and study requirements while supporting high-quality patient data and study delivery. This is a senior individual contributor role with responsibility for supporting site performance, resolving issues, maintaining study documentation and providing guidance and mentorship to junior CRAs. You will work closely with Clinical Operations, Project Management, sponsors and other cross-functional teams in a dynamic clinical research environment. Key Responsibilities: Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Germany. Ensure investigative sites comply with study protocols, ICH-GCP, applicable regulations, SOPs and project-specific requirements. Serve as a primary point of contact for assigned sites, managing site-related questions, issues, action items and protocol deviations through to resolution. Review clinical trial data, source documentation and study systems to ensure accuracy, completeness, data integrity and compliance. Support site selection, activation and recruitment activities, working with sites to achieve study milestones and patient recruitment targets. Ensure sites are appropriately trained on protocols, study systems, processes and applicable requirements throughout the study lifecycle. Maintain oversight of essential study documentation, including ISF and TMF, ensuring documents are complete, accurate and filed in a timely manner. Collaborate with sponsors, project teams, vendors and investigative sites to support study timelines, resolve issues and maintain effective working relationships. Participate in audits and inspections, Investigator Meetings, study meetings and other project activities as required. Provide mentoring and support to CRA I and II colleagues, participate in co-monitoring and CRA assessment activities, and contribute to process improvement initiatives. Skills & Qualifications Bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline; a Master’s degree is preferred. 4–6 years of relevant clinical research experience, with 7–9 years preferred. Strong clinical site monitoring experience across clinical trial activities from site start-up through close-out. Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements. Experience with Phase I–IV clinical trials preferred. Proficiency with clinical trial systems such as EDC, IRT, eTMF, CTMS and Microsoft Office, with experience in systems such as Medidata Rave or Oracle InForm preferred. Strong understanding of site management, including site activation, recruitment, training, issue resolution and maintenance of essential documentation. Excellent communication, interpersonal and relationship-management skills, with the ability to work effectively with investigative sites, sponsors and cross-functional teams. Strong organisational, problem-solving and prioritisation skills, with a high level of attention to detail and a sense of urgency. Ability to work independently, demonstrate sound judgement and manage competing priorities in a results-driven environment. Experience mentoring or supporting junior CRAs is preferred. Willingness and ability to travel approximately 40–60%, depending on project requirements and geographic location. Valid driver’s licence required. Fluent written and verbal English. What We Offer In addition, as an Alimentiv Employee, you’re also eligible for the following programs: - Education Reimbursement program for full-time employees - Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility) - One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.) - Working while visiting program – up to 4 weeks per year! - Flexible Summer Hours Program from May – September - Employee referral incentive – we know great people know other great people, and we think that warrants recognition! - Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment - Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team! Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility. Our Services - End-to-end GI clinical trial services, from protocol design through submission support - Central medical imaging management and endoscopic reading - Precision medicine and biomarker solutions - Real-world evidence and clinical consulting - Histopathology and lab services through AcelaBio How to Apply To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn’s Easy Apply. Resumes must be submitted in English. Equal Opportunity and Accessibility Alimentiv is committed to building a diverse, inclusive and respectful workplace. We are an equal opportunity employer and consider all qualified applicants for employment without regard to race, colour, ethnicity, national origin, religion or belief, sex, gender identity or expression, sexual orientation, age, marital or family status, disability, or any other characteristic protected by applicable law.    Accommodations are available upon request for persons with disabilities throughout the recruitment and selection process. Requests can be directed to recruitment@alimentiv.com . Stay Alert to Recruitment Scams Alimentiv is aware of a continued increase in phishing scams, which use various methods of attack via email, text, voice and social media, including individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from company email addresses containing "@alimentiv.com". If you are contacted about an open job at Alimentiv, please verify the domain of the sender's email address and confirm that you are being asked to apply on this website. If something doesn't feel right, we encourage you to verify before responding. If you believe you have been the victim of a phishing scam, please contact your local government cyber authority to report it.

Sr. Clinical Research Associate (Germany)

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