Senior Clinical Research Associate
Vor 2 Tagen
Senior CRA – Germany Therapeutic Area: Cell & Gene Therapy Location: Germany Freelance contract (min 0.8 FTE) About the Role We are seeking an experienced Senior Clinical Research Associate to join an innovative, fast-growing biopharmaceutical organisation advancing next-generation cell and gene therapies . You will play a key role in overseeing complex clinical trials, ensuring high-quality monitoring, and driving operational excellence across German study sites. This is an opportunity to work at the cutting edge of science, supporting transformative therapies that have the potential to redefine treatment outcomes for patients with severe and rare diseases. Key Responsibilities Perform independent on-site and remote monitoring activities in accordance with ICH-GCP, local regulations, and study protocols. Ensure site compliance , quality data collection, and timely resolution of issues. Act as the primary point of contact for site staff, establishing strong, collaborative relationships. Proactively identify risks and implement mitigation strategies to keep studies on track. Support feasibility assessments, site selection, initiation, routine monitoring, and close-out visits. Provide mentorship to junior CRAs and contribute to best practice development. Prepare study reports and maintain essential regulatory documentation. Partner with cross-functional teams (Regulatory, Project Management, Data Management, Safety). Contribute to inspection readiness and support regulatory audits as needed. Requirements 3–5+ years of independent monitoring experience as a CRA, with solid exposure to complex, interventional studies. Direct experience in cell & gene therapy trials (e.g., CAR-T, gene-modified cell therapies, AAV vectors). Strong understanding of GCP/ICH guidelines and German regulatory requirements. Bachelor’s or Master’s degree in Life Sciences or related field. Ability to work autonomously and manage multiple priorities in a fast-paced environment. Excellent communication skills in German and English . Willingness to travel nationally (approx. 40–60%). About Planet Pharma: Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
-
Senior Clinical Research Associate
vor 3 Wochen
Deutschland AL Solutions VollzeitSenior Clinical Research Associate – Germany (Home-Based, French Speaking) Chloe O’Shea is pleased to be working with a small global CRO recognised for driving innovation and excellence in clinical development. We are seeking an experienced Clinical Research Associate to join a sponsor-dedicated team, home-based in Germany. This is a unique opportunity...
-
Clinical Research
Vor 7 Tagen
Deutschland Xena (Techstars '23) Vollzeit 35.000 € - 45.000 €Travel: ~1 week/quarter to clinical sites in US & EU (Mary Washington, UCSD, Cleveland Clinic) Language: English (fluent) About XENA XENA is building the intelligence layer for surgery, transforming MRI into AI-powered 3D surgical workflows that support teams from disease detection through planning and intraoperative execution. What we do Our AI identifies...
-
Klinischer Monitor
Vor 7 Tagen
Deutschland Xena (Techstars '23) Vollzeit 35.000 € - 45.000 €Travel: ~1 week/quarter to clinical sites in US & EU (Mary Washington, UCSD, Cleveland Clinic) Language: English (fluent) XENA is building the intelligence layer for surgery, transforming MRI into AI-powered 3D surgical workflows that support teams from disease detection through planning and intraoperative execution. Our AI identifies disease,...
-
Experienced Clinical Research Associate
Vor 4 Tagen
Deutschland Medpace Vollzeit 7.500 €Job Summary Our clinical activities are growing rapidly, and we are currently seeking an Experienced Clinical Research Associate to join our Clinical Operations team in Germany. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous...
-
Senior Director
Vor 7 Tagen
Deutschland Discover International VollzeitA fast-growing Biopharma CDMO is seeking an experienced Senior Director of Clinical Manufacturing to oversee all clinical-phase production activities at a specialised biologics facility in Germany. The site supports global biotech partners across Phase I–III programs, with capabilities spanning USP, DSP, aseptic filling, and viral/vector processing. This...
-
Clinical Scientist
vor 4 Wochen
Deutschland Tubulis GmbH VollzeitBe part of our team As a Clinical Scientist (m/f/d) and member of our Clinical Development team, you will support the planning and execution of full life-cycle development of our antibody-drug conjugates (ADCs) global clinical trials. You will support the review, analysis, and interpretation of clinical trial data, contribute to the development of critical...
-
Research Support
vor 2 Wochen
Deutschland Avant Health VollzeitCompany Description Avant Health is a clinical research organization and a strategy consulting firm that specializes in designing and implementing clinical and observational research across north America, Europe and other parts of the world. At Avant Health, we help identify, create and communicate value of healthcare and pharmaceutical products and...
-
Senior Research And Development Engineer
vor 2 Wochen
Deutschland Skills Alliance VollzeitThis opportunity is with a growing European medical device innovator focused on developing next-generation, minimally invasive Class III cardiovascular technologies . The company is advancing implantable solutions designed to improve treatment options for patients with structural heart disease , including novel approaches to valve repair. Supported by strong...
-
Research Fellowship, Germany
vor 2 Wochen
Deutschland Avant Health VollzeitCompany Description Avant Health is a clinical research organization and a strategy consulting firm that specializes in designing and implementing clinical and observational research across north America, Europe and other parts of the world. At Avant Health, we help identify, create and communicate value of healthcare and pharmaceutical products and...
-
Senior Clinical Scientist
Vor 6 Tagen
Deutschland Autolus Ltd VollzeitRole Summary The current position will be in clinical development in the area of Hematology /Oncology with Advanced Therapy Investigational Medicinal Products (ATIMPs). The Clinical Scientist (Manager) using clinical, scientific and technical disciplines supports high quality protocol development, study execution and data interpretation. They will be...
