Senior Bioanalytical Operations Specialist

Ascendis Pharma A/S; Gentofte Kommune; Remote; DKK 700,000 - 900,000; Full time

Job summary

Ascendis Pharma A/S in Denmark is seeking a professional to join the Bioanalytical Operations team. You will manage all bioanalytical operational aspects of clinical trials and collaborate with cross-functional teams in a fast-paced environment.

Based in Hellerup, you will report to Vice President Britta Bysted and coordinate with external labs, ensuring timelines, data transfer, and adherence to GCP standards throughout the trial lifecycle.

Qualifications

• Bachelor's degree in natural science or nursing/lab technician background with 5+ years in pharmaceutical drug development.
• Strong insights into GCP.
• Experience with planning and executing clinical trials and related documentation.
• Proven track record with external vendors (special and central laboratories).
• 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 our area in the cross-functional trial teams, working closely with clinical operations, data management, clinical trial supplies among others.
• Support bioanalytical outsourcing activities in close collaboration with outsourcing department, including study-specific contract set-up, management of POs and invoices, and relevant communication with vendors.
• Provide input, review and approval, where applicable of relevant sections in study-related documents i.e., protocols/ICFs, data transfer specifications, central lab SOWs, laboratory manuals, SOPs, assay performance, bioanalytical reports, etc.
• Contribute to development and continuous improvement of bioanalytical operational processes and supporting documentation

Skills

GCP knowledge

Clinical trial planning

Vendor management

Bioanalytical operations

IT skills

Education

Bachelor degree in natural science

Nurse or laboratory technician background

Job description

Ascendis Pharma A/S in Denmark is seeking a professional to join the Bioanalytical Operations team. You will manage all bioanalytical operational aspects of clinical trials and collaborate with cross-functional teams in a fast-paced environment.

Based in Hellerup, you will report to Vice President Britta Bysted and coordinate with external labs, ensuring timelines, data transfer, and adherence to GCP standards throughout the trial lifecycle.