Senior Bioanalytical Operations Lead – Clinical Trials

Ascendis Pharma; Gentofte Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ascendis Pharma is seeking a passionate professional to join the Bioanalytical Operations team in Clinical Pharmacology & Bioanalysis, based in our Hellerup office. You will drive bioanalytical operational activities across trials, working with cross-functional global teams to meet timelines and quality standards.

The role emphasizes collaboration with external labs and vendors, ensuring compliant, efficient sample workflows and data handling in a fast-paced environment.

Qualifications

• Bachelor degree in natural science or nursing, lab technician, or similar with at least 5 years in pharmaceutical drug development.
• Strong knowledge of GCP and regulatory requirements.
• Experience coordinating with external labs and vendors.

Responsibilities

• Oversee all bioanalytical operational aspects of clinical trials on assigned projects and timelines.
• Manage logistics and timelines for sample analysis, handling, shipment, data transfer and disposition.
• Coordinate with cross-functional teams (clinical operations, data management, CT supplies).
• Support outsourcing activities, contract setup, PO management, and vendor communications.
• Review study-related documents (protocols, data transfer specs, SOWs, SOPs, reports).
• Contribute to process improvements in bioanalytical operations.

Skills

GCP experience

Trial operations

Vendor management

Education

Bachelor's in natural sciences

Job description

Ascendis Pharma is seeking a passionate professional to join the Bioanalytical Operations team in Clinical Pharmacology & Bioanalysis, based in our Hellerup office. You will drive bioanalytical operational activities across trials, working with cross-functional global teams to meet timelines and quality standards.

The role emphasizes collaboration with external labs and vendors, ensuring compliant, efficient sample workflows and data handling in a fast-paced environment.