Senior Clinical Research Associate

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

📋 Description

• Perform site monitoring duties for clinical trials.

• Offer oversight, leadership, and direction in the management and execution of clinical trials to ensure adherence to compliance and quality standards.

• Analyze monitoring visit reports and conduct co-monitoring and evaluation visits when necessary.

• Ensure timely and appropriate investigator site visits.

• Collaborate with relevant cross-functional departments to facilitate negotiations and resolve issues related to clinical trial monitoring.

• Conduct qualification, initiation, interim, and close-out visits, both remotely and onsite.

• Generate precise and timely monitoring visit reports that document site-related issues, resolutions, actions taken, protocol deviations, study progress, and enrollment status.

• Keep regular communication with study sites to guarantee compliance with protocol and GCP standards.

• Assist with adverse event reporting and ensure that SAE reports are reconciled with source documentation and CRFs.

⛳️ Requirements

• BS/BA degree from an undergraduate program (preferably in life sciences or a related field).

• At least 3 years of experience within the pharmaceutical, biotechnology, or CRO sectors.

• Minimum of 2 years of clinical monitoring experience, including 1 year in a management role.

• A minimum of 2 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry within the EU.

• Capability to independently manage monitoring activities.

• Excellent command of the English language, both written and spoken.

• Proficient in the local language, both written and spoken, in the region where monitoring activities are conducted.

• Professional, reliable, and disciplined demeanor.

• Understanding of clinical research, ICH GCP, and local regulations.

• Familiarity with regulatory and ethical requirements.

🏝️ Benefits

• Opportunities for professional development.

• Global travel opportunities.

• Flexible work arrangements.