Clinical Operations Lead/Biomarker (m/f/d)

Clinical Operations Lead/Biomarker (m/f/d)

The ideal candidate has a scientific education, with around 3 years of experience with a minimum of 1 year in clinical operations in pharma. You should have good experience with vendor and project management working in a global matrix environment. Experience as a biomarker in a pharma and clinical setting is required.

General Information:

Latest possible start date: end of July

End date: 1 year duration, with possibility of extension

Workplace: Basel

Remote/Home Office: onsite will be required, details to be discussed with HM

Tasks & Responsibilities

• Provide biomarker operational excellence by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for clinical studies.
• Collaborate with cross-functional STUDY and Biomarker Teams to execute biomarker operational strategies.
• Lead identification, selection and oversight of Biomarker Vendors, ensuring quality delivery and performance.
• Develop and oversee biomarker analysis timelines, budget, risk, compliance and quality, ensuring study adherence to ICH/GCP and SOPs.
• Lead and influence by establishing yourself as a leader within the team, inspiring others to perform at their best and learn from biomarker operations best practices. You will be shaping our capabilities and evolving your role over time.

Qualifications and Skills

• Min Bachelor/Master in Life Sciences (biology and/or chemistry) (PhD & Post Docs are considered)
• Minimum 3 years of experience in a clinical research setting, including at least 1 year working in pharma clinical operations
• Strong experience with vendor and project management
• Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines
• Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
• Previous experience in life sciences, pharmaceutical/biotechnology R&D environment
• Laboratory experience in a clinical / biological / diagnostic setting

Seniority Level

Mid-Senior level

Employment Type

Contract

Job Function

Management, Project Management, and Manufacturing

Industries

Pharmaceutical Manufacturing and Biotechnology Research