Bioanalytical Operations Lead — Clinical Trials

Ascendis Pharma; Hellerup; On-site; DKK 700,000 - 900,000; Full time

Job summary

Ascendis Pharma is seeking a passionate Bioanalytical Operations professional to lead operational aspects of clinical trials from its Hellerup headquarters. You will coordinate sample analysis timelines, liaise with cross-functional teams, and support outsourcing activities.

A 5+ year pharma background and strong GCP knowledge are essential. Based in Denmark, the role reports to the VP and involves 3–7 travel days per year; office located at Tuborg Boulevard 12, Hellerup.

Qualifications

• Bachelor degree in natural science or trained as nurse, laboratory technician, or similar with at least 5 years' experience with pharmaceutical drug development.
• Strong IT skills.

Responsibilities

• Responsible for all bioanalytical operational aspects of clinical trial conduct on assigned projects according to trial timelines and priorities.
• Manage logistics and timelines for execution of bioanalytical sample analysis, from sample collection and processing, shipment, testing, data transfer, including sample tracking, reconciliation, and final sample disposition.
• Represent area in cross-functional trial teams, working with clinical operations, data management, clinical trial supplies, among others.
• Support bioanalytical outsourcing activities with outsourcing department; study-specific contract setup, PO/invoice management, vendor communication.
• Provide input and approval of study-related documents (protocols, ICFs, data transfer specs, central lab SOWs, SOPs, etc.).
• Contribute to development and continuous improvement of bioanalytical operational processes and supporting documentation.

Skills

GCP knowledge

Clinical trial planning

Vendor management

IT skills

Education

Bachelor's degree in natural science

Nurse / lab technician training

Job description

Ascendis Pharma is seeking a passionate Bioanalytical Operations professional to lead operational aspects of clinical trials from its Hellerup headquarters. You will coordinate sample analysis timelines, liaise with cross-functional teams, and support outsourcing activities.

A 5+ year pharma background and strong GCP knowledge are essential. Based in Denmark, the role reports to the VP and involves 3–7 travel days per year; office located at Tuborg Boulevard 12, Hellerup.