Contractor, Clinical Operations

About the role

The Contractor, Clinical Operations, leads and manages all aspects of clinical trial execution across therapeutic areas, ensuring compliance with regulatory standards and company SOPs.

Responsibilities

• Plan, execute, and report on clinical trials, including protocol development, site selection, data review, and study reporting.
• Collaborate with internal teams and external partners to develop clinical strategies and trial design.
• Evaluate scientific literature and assist in preparing study documents, informed consent forms, and regulatory submissions.
• Manage site negotiations, budgets, investigator meetings, and monitor trial progress.
• Ensure data quality, support regulatory submissions, and interpret clinical data for reports and publications.
• Support project timelines, budgets, and communicate trial status to stakeholders.
• Leading trial planning and execution.
• Managing site relationships and budgets.
• Ensuring regulatory compliance.
• Reviewing clinical data.
• Supporting regulatory documentation.

Qualifications & Skills

• Bachelor’s degree in a relevant field with at least 8 years of experience in clinical operations within the pharmaceutical, biotech, or related sectors.
• Knowledge of drug development, clinical trial processes, and adherence to GCP, GMP, and ICH guidelines.
• Strong communication, organizational, and analytical skills with the ability to work independently and collaboratively.
• Proficiency in Microsoft Word and Excel.
• Preferred: Experience with IND/NDA submissions, clinical monitoring, and medical writing.