Senior Clinical Research Associate

Upsilon Global; Deutschland; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Upsilon Global is seeking a Senior Clinical Research Associate (Oncology) based in Germany to independently manage investigative sites from startup through close-out.

You will lead SQVs, SIVs, IMVs/RMVs and COVs, ensure data quality, manage regulatory documents, and oversee TMF/eTMF maintenance while complying with ICH-GCP and EU/German regulations.

Travel to sites is required as part of monitoring activities.

Qualifikationen

• 5+ years of clinical research experience.
• Experience managing multiple sites and studies independently.
• Strong knowledge of ICH-GCP and EU/German clinical trial regulations.
• Hands-on experience with SIVs, IMVs/RMVs and COVs.

Aufgaben

• Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs) carried out.
• Interim/Remote Monitoring Visits (IMVs/RMVs) conducted and documented.
• Close-Out Visits (COVs) and site management overhead.
• Source data verification and data review across studies.
• Regulatory and essential document management and TMF/eTMF upkeep.
• Risk identification and issue resolution during monitoring.
• Monitoring visit reports and timely follow-up actions.
• Support audits and regulatory inspections as needed.

Kenntnisse

Site management

Monitoring visits

Regulatory compliance

EDC

CTMS

eTMF

Travel readiness

Ausbildung

Bachelors degree in Life Sciences

Tools

EDC

CTMS

eTMF

Jobbeschreibung

Senior Clinical Research Associates – Oncology

Are you an experienced CRA looking for your next opportunity within Oncology clinical research?

We are currently looking for 5 Senior CRAs based in Germany to support exciting oncology clinical trials, offering the opportunity to take real ownership of your sites and work across the full clinical trial lifecycle.

The Opportunity

As a Senior CRA, you will independently manage and oversee investigative sites from study start-up through close-out, working closely with investigators, site teams and cross-functional stakeholders to ensure high-quality study delivery.

Your responsibilities will include:

• Site Qualification Visits (SQVs)
• Site Initiation Visits (SIVs)
• Interim/Remote Monitoring Visits (IMVs/RMVs)
• Close-Out Visits (COVs)
• Site management and oversight
• Source data verification and data review
• Regulatory and essential document management
• TMF/eTMF maintenance
• Risk identification and issue resolution
• Monitoring visit reports and follow-up
• Supporting audits and regulatory inspections

What We’re Looking For

• 5+ years of clinical research experience
• Experience managing multiple sites and studies independently
• Strong knowledge of ICH-GCP and EU/German clinical trial regulations
• Hands-on experience with SIVs, IMVs/RMVs and COVs
• Experience using EDC, CTMS and eTMF systems
• Based in Germany and able to travel to investigative sites as required
• Bachelor’s degree in Life Sciences or a related scientific discipline

This is an excellent opportunity for experienced CRAs who enjoy autonomy, site ownership and complex oncology studies and are looking to take the next step in their clinical research career.