Senior Clinical Research Manager

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

📋 Description

• Oversee clinical monitoring activities and the performance of the CRA team throughout clinical trials.

• Ensure adherence to quality standards and compliance with ICH-GCP, local regulations, company SOPs, and regulatory guidelines.

• Allocate CRA resources effectively and evaluate workloads to fulfill study deliverables.

• Ensure CRAs possess the necessary monitoring knowledge and skills for high-quality delivery.

• Manage the performance and quality metrics of CRAs.

• Strengthen relationships with sites and support the delivery of trials.

• Collaborate with cross-functional teams to facilitate study and site milestone delivery.

• Conduct assessment visits and accompany others on visits as needed.

• Identify issues and formulate resolution strategies.

• Contribute to process optimization while managing risk escalation and resolution.

• Assist with site audits, inspections, and Site Compliance Visits, including follow-up on corrective actions.

• Review and authorize CRA-related expenses while identifying opportunities for cost savings.

• Mentor junior Clinical Research Managers and promote learning opportunities.

• Lead strategic initiatives and task forces aimed at enhancing clinical operations.

• Recruit, hire, and onboard new team members.

• Delegate tasks, provide necessary resources, and foster team communication and collaboration.

• Conduct performance evaluations and deliver constructive feedback.

• Address personnel issues while supporting career development.

⛳️ Requirements

• A minimum of 7 years of industry experience in the pharmaceutical, CRO, or a related field.

• At least 4 years of experience in people management or project management within progressive clinical research is preferred.

• A comprehensive understanding of the drug development process.

• Expert knowledge of international standards, including ICH GCP, as well as health authority requirements.

• Familiarity with all aspects of monitoring and trial execution.

• Previous experience as a CRA is preferred.

• Exceptional interpersonal, organizational, written, and verbal communication skills.

• Proven team leadership experience.

• Experience in Oncology is highly recommended.

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

• Fluent in written and spoken English.

• Willingness to adapt to business travel as required.

• A valid driver’s license in applicable countries.

• A Bachelor’s degree or higher in a scientific or healthcare discipline.

• Must adhere to ICH-GCP, local regulations, and company SOPs.

🏝️ Benefits

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

• Opportunity for incentive compensation plans for commercial roles.

• Discretionary equity awards.

• Participation in the Voluntary Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance options.

• 401(k) retirement plan.

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

• Life insurance benefits.

• Paid Time Off.

• Wellness benefits.

• Reasonable accommodations provided during the job application process.