Clinical Trial Manager II – Project Management, CRA

This is a fully remote position, open to applicants in Chile.

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables with an emphasis on patient safety, protocol/GCP/regulatory compliance, and data integrity.

• Manages site interactions from activation to closeout, which may encompass patient recruitment, investigator payments, and other pertinent activities.

• Evaluates the study's scope of work, budget, and protocol content, ensuring the clinical project team (CRAs/Central Monitors) understands the contractual obligations and parameters.

• Utilizes previous clinical experience, operational data, metrics, and reports to identify potential risks to clinical trial management deliverables, escalating any risks to the project manager.

• Applies strategic thinking and problem-solving abilities to suggest and implement risk mitigation strategies.

• Works collaboratively with other functional leaders such as Study Start-Up, Patient Recruitment, and Data Management to coordinate delivery handoffs and achieve expected study milestones.

⛳️ Requirements

• Proficient in project management with prior experience as a CRA.

• Bachelor’s degree or RN in a relevant field or a comparable combination of education, training, and experience.

• Proven ability to lead and align teams in attaining project milestones.

• Demonstrated capability of functioning in an international setting.

• Proven expertise in site management and monitoring (clinical or central).

• Preferred background in risk-based monitoring.

• Demonstrated understanding of clinical trial management financial principles and budget oversight.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory standards.

• Must exhibit strong computer skills.

• Proven ability to apply problem-solving techniques to address complex challenges and employ a risk management strategy to identify and mitigate potential risks to the successful execution of a clinical research project.

• Exhibits critical thinking to identify the cause of issues and formulate appropriate solutions.

• Moderate travel may be necessary, approximately 20% of the time.

🏝️ Benefits

• We are dedicated to nurturing our employees through career development and progression, supportive and engaged management, technical and therapeutic area training, peer recognition, and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself.