Associate Clinical Research Manager

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

📋 Description

• Supervise clinical monitoring functions and evaluate CRA team performance

• Ensure adherence to ICH-GCP, local regulations, and company SOPs

• Guide the CRA team toward achieving organizational objectives and exceptional performance

• Allocate CRA resources and evaluate workload to fulfill study deliverables

• Ensure CRAs possess the necessary monitoring knowledge and skills to execute activities with high quality

• Oversee CRA performance and quality metrics

• Enhance site relationships to improve performance and trial execution

• Review monitoring quality and address compliance issues

• Collaborate with cross-functional teams to support study and site milestone achievements

• Conduct assessment visits and accompany visits as necessary

• Identify challenges and formulate resolution strategies

• Contribute to process improvement and manage risk identification and resolution

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

• Ensure follow-up and corrective actions for identified issues

• Recruit, hire, and onboard new team members

• Delegate tasks based on individual strengths and team goals

• Provide resources and support to team members

• Foster communication and collaboration within the team and with other departments

• Conduct performance reviews and deliver constructive feedback

• Mentor team members and support their career development

• Address personnel matters promptly and equitably

⛳️ Requirements

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

• Fluent in both written and spoken English

• Minimum of 5 years of industry experience in pharmaceuticals, CRO, or a related field

• Comprehensive understanding of the drug development process

• Expert knowledge of international standards (ICH-GCP) and health authority regulations

• Familiarity with all aspects of monitoring and trial execution

• Previous experience as a CRA preferred

• Exceptional interpersonal skills

• Strong organizational capabilities

• Effective written and verbal communication abilities

• Experience in Oncology is highly recommended

• Willingness to travel as required by business needs

• Valid driver's license in applicable countries

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

• Advanced degrees are preferred

🏝️ Benefits

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

• Incentive compensation plan eligibility for commercial roles

• Discretionary equity awards

• Optional participation in the Employee Stock Purchase Plan

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k) plan

• FSA/HSA options

• Life insurance

• Paid Time Off

• Wellness programs