Senior Clinical Research Manager

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

📋 Description

• Supervise clinical monitoring operations and evaluate the performance of the CRA team to ensure adherence to ICH-GCP standards, local regulations, and company SOPs.

• Allocate CRA resources effectively and conduct continuous assessments to maintain a balanced workload for quality monitoring and to achieve study objectives.

• Ensure that CRAs possess the necessary level of monitoring expertise and skills.

• Manage CRA performance and quality metrics, addressing any issues that arise.

• Enhance site relationships to improve performance and uphold the company’s reputation in trial delivery.

• Review monitoring quality and resolve issues to maintain compliance with regulatory standards.

• Facilitate the achievement of study/site milestones in partnership with cross-functional teams.

• Review and authorize expenses related to CRA activities.

• Identify opportunities for cost savings and operational efficiency.

• Provide mentorship and support to junior Clinical Research Managers (CRMs).

• Lead and participate in strategic initiatives and task forces.

⛳️ Requirements

• Proficient in both written and spoken English.

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

• A minimum of 4 years in people management or project management within progressive clinical research, preferably in the biotech or pharmaceutical sector, or CRO industry.

• Comprehensive understanding of the drug development process, with in-depth knowledge of international standards (ICH GCP) and health authority regulations.

• Familiarity with all facets of monitoring and trial execution, with prior experience as a CRA being advantageous.

• Exceptional interpersonal skills, strong organizational abilities, and effective written and verbal communication skills, along with demonstrated team leadership experience.

• Experience in Oncology is highly preferred.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness