Senior Clinical Research Manager

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

📋 Description

• Supervise clinical monitoring processes and evaluate the performance of the CRA team.

• Assign CRA resources and analyze workloads to fulfill study objectives.

• Ensure CRAs conduct monitoring activities with the necessary knowledge, skills, quality, and adherence to compliance.

• Oversee CRA performance and quality metrics in alignment with ICH-GCP, SOPs, and local regulations.

• Enhance site relationships and maintain high standards of trial delivery quality.

• Assess monitoring quality and address regulatory and compliance challenges.

• Facilitate the achievement of study and site milestones by collaborating with cross-functional teams.

• Carry out assessment visits and accompanied visits to evaluate CRA monitoring proficiency.

• Spot issues and formulate resolution strategies.

• Contribute to process improvement and manage the escalation and resolution of risks.

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

• Review and authorize CRA-related expense claims.

• Identify opportunities for cost savings and efficiency while ensuring quality and compliance are upheld.

• Mentor junior Clinical Research Managers.

• Lead and participate in clinical operations taskforces and strategic initiatives.

• Recruit, hire, and onboard new team members.

• Delegate tasks and provide resources to enhance team effectiveness.

• Foster communication and collaboration while serving as an escalation point.

• Conduct performance assessments and offer constructive feedback.

• Guide team mentoring, development, issue resolution, and career advancement support.

⛳️ Requirements

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

• Proficient in both written and spoken English.

• At least 7 years of experience in the pharmaceutical, CRO, or a related industry.

• A minimum of 4 years in people management or project management within progressive clinical research is preferred.

• Comprehensive understanding of the drug development lifecycle.

• In-depth knowledge of international standards, including ICH GCP, and requirements from health authorities.

• Familiarity with monitoring and trial execution.

• Previous experience as a CRA is preferred.

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

• Proven experience in team leadership.

• Experience in oncology is highly recommended.

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

• 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.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• FSA/HSA.

• Life Insurance.

• Paid Time Off.

• Wellness benefits.

• Support for reasonable accommodations.