Description

You will support the start-up, maintenance, and close-out of Phase I-IV clinical studies.

Responsibilities

• Manage study timelines, documentation, and communications to ensure execution remains on track.
• Coordinate operational activities for the collection, delivery, and analysis of biological samples.
• Direct vendor selection and manage deliverables from CROs and other external partners.
• Review clinical study protocols, sample management plans, and informed consent documents.
• Identify operational challenges and collaborate with stakeholders to implement solutions.

Required Skills

• MA, MS, PharmD, or PhD with 2+ years of relevant clinical or life sciences experience; or BA, BS, or RN with 4+ years.
• Experience managing the work of external vendors.
• Comprehensive knowledge of FDA and EMA regulations.
• Deep understanding of ICH guidelines and Good Clinical Practice (GCP).
• Knowledge of the full clinical study management cycle from start-up to close-out.
• Proficiency in Clinical Operations principles, processes, and standards.
• Ability to move between projects and adapt to changing study requirements.

Preferred Skills

• Bachelor's degree in a life sciences or clinical field.
• 3+ years of tenure in clinical trial management roles.

Key Skills

Education

Bachelor's degree