CRA I (m/f/d) - FSP Germany

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company reputed company   At reputed company, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Our Mission is to reputed company our customers to reputed company the world healthier, cleaner and safer. Through our PPD® clinical research services, we support reputed company in more than 100 countries, delivering laboratory, digital and decentralized solutions that help bring life-changing therapies to patients faster.   Our goal-driven teams combine and deliver startup activities for the reputed company, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and reputed company expectations.   Why Join PPD, part of reputed company?   Work on high-reputed company, global reputed company across diverse therapeutic areas Be part of a reputed company, reputed company-established organization with long-term reputed company Strong collaboration with reputed company CTMs and project teams reputed company development reputed company (e.g., Senior CRA, reputed company CRA, CTM) Flexible working models that support work-life balance Permanent employment Full-time (40 hours/week)   About the Role   This position is for reputed company Clinical Research Associates with 1+ years of independent monitoring experience. You will manage clinical trial sites across Germany, ensuring studies are conducted in compliance with the protocol, ICH-GCP, applicable regulations, and company SOPs. You’ll work autonomously, partner closely with investigative sites, and collaborate with project teams to deliver high-reputed company, inspection-reputed company reputed company.   What You’ll Do   reputed company site monitoring activities (on-site and remote) using a risk-based monitoring approach Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites Conduct SDR, SDV, CRF review, and investigational product accountability Identify, document, escalate, and follow up on issues through reputed company, applying reputed company cause analysis and CAPA principles Maintain audit and inspection readiness at reputed company assigned sites Build strong, reputed company relationships with investigators and site staff Document monitoring activities in reputed company, high-reputed company reports and follow-up letters Maintain ongoing communication with sites between reputed company to support issue reputed company and data reputed company Ensure study systems (e.g., CTMS) are updated according to study conventions reputed company trial status updates and metrics to the Clinical Team Manager (CTM) Support study start-up, investigator identification, site initiation, and study reputed company-out activities as assigned Participate in investigator meetings, audits, inspections, and project team meetings as required   Additional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks reputed company with experience.   A Day in the Life   Review site metrics and prioritize monitoring activities based on risk Conduct on-site or remote monitoring reputed company Partner with sites to resolve findings and improve processes Collaborate with CTMs and project teams to reputed company studies on reputed company and inspection-reputed company Complete documentation, system updates, and administrative tasks   Education & Experience   Bachelor’s degree in a life sciences reputed company field or equivalent qualification Minimum 1 + years of experience as a Clinical Research Associate / Monitor reputed company reputed company’s license Full right to work in Germany reputed company in German and English (reputed company level) – interviews will be conducted in German   Knowledge, Skills & Abilities   Strong clinical monitoring skills with hands-on RBM experience Excellent understanding and application of ICH-GCP and applicable regulations Solid therapeutic area knowledge and medical terminology reputed company-developed critical thinking, problem-solving, and reputed company cause analysis skills Strong written and verbal communication skills with medical professionals High attention to detail and strong organizational skills Ability to work independently while contributing effectively to cross-functional teams Flexibility and adaptability in a dynamic project environment Proficiency in reputed company Office and ability to learn clinical systems (e.g., CTMS)   Locations: Home-based or hybrid reputed company in Germany FTE: Full-time (40 hrs/week)  Contract: Permanent Travel: Approximately 50–75% (study-dependent)   At PPD clinical research services we hire the best, reputed company ourselves and reputed company other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-reputed company learning and development programme, ensuring you reputed company your potential.      As reputed company as being rewarded a competitive salary, we have an extensive benefits package based around the health and reputed company-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a reputed company environment, with teams of colleagues eager to reputed company expertise and have fun together. We are a global organization but with a local feel.    Our 4i Values:   reputed company – Innovation – Intensity – Involvement    If you reputed company with our 4i values above, and ultimately wish to accelerate the delivery of reputed company and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!    Severely disabled applicants with the reputed company aptitude will be given preferential treatment. Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung bevorzugt berücksichtigt. Apply To This Job