Senior Clinical Research Associate

Planet Pharma; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A biopharmaceutical organisation in Germany is seeking a Senior Clinical Research Associate to oversee clinical trials in cell and gene therapy. Responsibilities include site monitoring, ensuring compliance, and mentoring junior staff. Candidates should have 3–5+ years of CRA experience and a relevant degree. Excellent communication skills in both German and English are crucial. This freelance role provides autonomy and involves some national travel (approx. 40–60%).

Qualifikationen

• 3–5+ years of independent monitoring experience as a CRA.
• Direct experience in cell & gene therapy trials.
• Ability to work autonomously in a fast-paced environment.

Aufgaben

• Perform independent on-site and remote monitoring activities.
• Ensure site compliance and quality data collection.
• Act as primary point of contact for site staff.
• Identify risks and implement mitigation strategies.
• Support feasibility assessments and site selection.
• Provide mentorship to junior CRAs.

Kenntnisse

Independent monitoring experience

Strong understanding of GCP / ICH guidelines

Excellent communication skills in German and English

Ausbildung

Bachelor’s or Master’s degree in Life Sciences

Jobbeschreibung

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.

www.planet-pharma.com