Senior Clinical Research Associate – m/f/d

This is a fully remote position, open to applicants in Germany.

📋 Description

• Operate effectively as a part of a Project Team.

• Initiate, oversee on-site and/or remote monitoring, and finalize study sites during the conduct of the study.

• Supervise clinical trials in accordance with company and sponsor SOPs, GCP, ICH guidelines, and relevant regulations.

• Execute monitoring activities to evaluate subject safety, data integrity, and overall quality.

• Confirm informed consent procedures and adherence to the protocol.

• Assess CRFs and subject source documentation for accuracy and validity.

• Ensure proper management and accountability of Investigational Products.

• Draft Monitoring Visit Reports, document findings along with corrective and preventive actions, update tracking systems, and escalate issues as necessary.

• Provide sites with identified concerns and necessary action items.

• Submit site documents to eTMF or paper TMF, and ensure proper maintenance of the Investigator Site File.

• Engage in preparation and follow-up for audits or inspections.

• Order, transport, and reconcile clinical investigative supplies when necessary.

• Maintain accurate site-level information in the CTMS and other project systems.

⛳️ Requirements

• Bachelor’s Degree, preferably in a life science or nursing field; or equivalent qualifications.

• More than 1 year of relevant clinical experience or an academic background related to clinical trials or clinical development activities.

• Capability to thrive in a fast-paced environment with evolving priorities.

• Knowledge of basic medical terminology and the science related to assigned drugs and therapeutic areas.

• Familiarity with Good Clinical Practice regulations and ICH guidelines.

• Ability to work autonomously and within a team matrix organization.

• Excellent written and verbal communication skills.

• Proficiency in both English and German.

• Strong organizational skills.

• Technologically adept with proficient software and computer skills.

• Willingness to travel up to 60–80%, including overnight and international travel if applicable.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.

• A team dedicated to making a positive impact on patients' lives.