Senior Biosciences Study Lead Manager

IQVIA Laboratories; Town of Ithaca (NY); On-site; USD 80,000 - 167,000; Full time

Job summary

The IQVIA Laboratories Ithaca site is seeking a Manager - Biosciences Study Lead to guide a team of study leads in bioanalytical studies and deliverables. You will drive study execution in a regulated environment and serve as a domain expert on study leadership activities.

You will coach staff, coordinate with QA, project management, technical writing, and laboratory teams to ensure on-time completion while meeting scientific and regulatory standards, and you will engage with customers as needed.

Qualifications

• Bachelor's Degree required.
• 7 years’ related experience.
• GLP laboratory environment experience.
• LC-MS or immunoassay techniques knowledge.
• Experience with sample extraction and method validation.
• Equivalent combination of education, training, and experience may be accepted.

Responsibilities

• Lead and develop a team of study leads and conduct performance reviews.
• Oversight of projects across lifecycle: method development, validation, analysis, reporting, archiving.
• Serve as domain expert for study leadership activities.
• Collaborate with QA, PM, Technical Writing and lab teams to ensure schedule and regulatory standards.
• Monitor progress and escalate risks; provide status updates.
• Support communications with external customers and host visits.
• Lead investigations and CAPA activities; drive process improvement.
• Manage staff per policies and compliance requirements.

Skills

People leadership

GLP laboratory experience

Liquid chromatography

Mass spectrometry

Bioanalytical methods

Regulatory compliance

Client communication

Education

Bachelor's Degree

Job description

The IQVIA Laboratories Ithaca site is seeking a Manager - Biosciences Study Lead to guide a team of study leads in bioanalytical studies and deliverables. You will drive study execution in a regulated environment and serve as a domain expert on study leadership activities.

You will coach staff, coordinate with QA, project management, technical writing, and laboratory teams to ensure on-time completion while meeting scientific and regulatory standards, and you will engage with customers as needed.