Associate Clinical Research Manager

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

📋 Description

• Supervise clinical monitoring tasks and the performance of the CRA team.

• Ensure adherence to ICH-GCP, local regulations, and company Standard Operating Procedures (SOPs).

• Allocate CRA resources and evaluate workloads to fulfill study objectives.

• Confirm that CRAs have the necessary knowledge and skills for effective monitoring.

• Oversee CRA performance and quality metrics.

• Enhance relationships with sites and facilitate trial execution.

• Evaluate monitoring quality and address compliance challenges.

• Collaborate with cross-functional teams to support study and site milestones.

• Conduct assessment visits and attend accompanied visits when necessary.

• Identify challenges and devise resolution strategies.

• Contribute to process improvement and manage risk escalation and resolution.

• Assist with site audits, inspections, and Site Compliance Visits.

• Ensure corrective actions are taken and followed up on for identified issues.

• Recruit, hire, onboard, assign tasks, support, evaluate, mentor, and develop team members.

• Serve as a point of contact for issue escalation and feedback.

• Address personnel matters swiftly and fairly.

⛳️ Requirements

• Bachelor’s degree or higher in a scientific or healthcare-related field.

• At least 5 years of industry experience in pharmaceuticals, CRO, or a related area.

• Comprehensive understanding of the drug development lifecycle.

• In-depth knowledge of international standards (ICH-GCP) and health authority regulations.

• Familiarity with all aspects of monitoring and trial execution.

• Prior experience as a CRA is preferred.

• Exceptional interpersonal skills.

• Strong organizational abilities.

• Proficient in written and verbal communication.

• Experience in Oncology is highly desirable.

• Skilled in Microsoft Word, Excel, PowerPoint, and Outlook.

• Fluent in both written and spoken English.

• Willingness to travel for business as needed.

• Valid driver’s license in relevant countries.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Access to an incentive compensation plan for commercial roles.

• Opportunity for discretionary equity awards.

• Voluntary participation in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) or Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.

• Opportunities for professional development.