Clinical Research Manager
Company: Chemidox Clinical Trials
Location: Lancaster, California
Job Type: Full-Time
Schedule: Monday-Friday Onsite
Compensation: Competitive salary based on experience, qualifications, and leadership background.
About Chemidox
Chemidox Clinical Trials is a growing, multispecialty clinical research organization dedicated to advancing healthcare through high-quality clinical trials. We partner with leading pharmaceutical, biotechnology, and medical device companies to conduct Phase I-IV clinical studies across multiple therapeutic areas while maintaining an unwavering commitment to patient safety, regulatory excellence, and data integrity.
Our culture is built on ownership, accountability, communication, teamwork, continuous improvement, and operational excellence. We believe exceptional research begins with exceptional people.
Position Summary
The Clinical Research Manager is responsible for the overall operational leadership of the clinical research program. This position oversees daily research operations, develops high-performing teams, drives enrollment performance, ensures regulatory compliance, and supports the continued growth of the organization.
This is a high-ownership leadership position for someone who enjoys building systems, developing people, solving operational challenges, and creating an environment where research teams can consistently perform at a high level.
Working closely with investigators, sponsors, CROs, and executive leadership, the Clinical Research Manager will help shape the future direction of Chemidox's clinical research operations.
Primary ResponsibilitiesLeadership & Operations
- Provide operational leadership across all active clinical trials.
- Lead, coach, mentor, and develop study coordinators, recruiters, regulatory staff, and support personnel.
- Establish priorities and ensure operational goals are achieved.
- Promote a culture of ownership, accountability, teamwork, and continuous improvement.
- Conduct regular one-on-one meetings with team members.
- Lead daily, weekly, and monthly operational meetings.
- Monitor staff performance and provide coaching and feedback.
Clinical Research Operations
- Oversee study feasibility, site activation, enrollment, participant visits, data collection, monitoring, and study close-out.
- Maintain strong operational partnerships with Principal Investigators.
- Monitor enrollment projections and develop strategies to achieve recruitment goals.
- Ensure protocol compliance throughout the study lifecycle.
- Review enrollment metrics, protocol deviations, outstanding queries, timelines, and study performance.
- Support clinical procedures and research activities as operational needs require.
- Ensure accurate and timely documentation within CRIO and other research systems.
- Utilize Looker and other reporting tools to monitor site performance and support operational decision-making.
Regulatory Compliance & Quality
- Ensure compliance with FDA regulations, ICH-GCP, HIPAA, IRB requirements, and company SOPs.
- Oversee development, implementation, and continuous improvement of Standard Operating Procedures.
- Prepare the site for sponsor monitoring visits, audits, and regulatory inspections.
- Lead corrective and preventive action (CAPA) activities when necessary.
- Ensure essential regulatory documentation remains complete, accurate, and inspection-ready.
Sponsor & Investigator Relations
- Build and maintain strong relationships with sponsors, CROs, investigators, and clinical partners.
- Conduct recurring operational meetings with investigators.
- Keep investigators informed of enrollment progress, operational risks, and action plans.
- Represent Chemidox professionally during sponsor visits, investigator meetings, and feasibility discussions.
Business Growth & Financial Support
- Support feasibility evaluations and study selection.
- Assist leadership with study budgets, financial forecasting, and contract discussions.
- Identify opportunities to expand research services and improve operational capacity.
- Support strategic initiatives that contribute to organizational growth.
Problem Solving & Accountability
- Identify operational risks early and proactively develop solutions.
- Develop action plans with clear ownership and measurable timelines.
- Drive issues through resolution while maintaining transparency and accountability.
- Foster a culture where team members identify problems and propose solutions.
Qualifications
- 7–10+ years of progressive clinical research experience.
- Demonstrated leadership experience managing clinical research teams.
- Strong knowledge of FDA regulations, ICH-GCP, HIPAA, IRB requirements, and clinical research operations.
- Experience leading multiple clinical trials simultaneously.
- Proficiency with CRIO or comparable Clinical Trial Management Systems.
- Strong analytical, organizational, communication, and leadership skills.
- Ability to prioritize effectively in a fast-paced environment.
- Bachelor's degree in Life Sciences or a related field required.
- Advanced degree preferred.
- ACRP, SOCRA, PMP, Lean, or Six Sigma certifications are preferred but not required.
Who Will Thrive in This Role
We're looking for someone who:
- Leads by example.
- Takes ownership and follows through.
- Communicates proactively and transparently.
- Develops people and enjoys coaching others.
- Solves problems with urgency and professionalism.
- Builds strong relationships with investigators, sponsors, and team members.
- Uses data to drive operational decisions.
- Thrives in a fast-paced, growing organization.
- Is passionate about continuous improvement.
- Wants to help build one of the leading clinical research organizations in the region.
What We Offer
- Opportunity to lead a growing clinical research organization.
- High level of autonomy and operational ownership.
- Collaborative, supportive, and team-oriented culture.
- Exposure to Phase I-IV clinical trials across multiple therapeutic areas.
- Ongoing leadership development and professional growth.
- Health, dental, and vision insurance.
- Paid time off and paid holidays.
- Competitive compensation based on experience and qualifications.
Equal Opportunity Employer
Chemidox Clinical Trials is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to any characteristic protected by applicable federal, state, or local law.
How to Apply
Please submit your resume along with a brief statement describing your interest in clinical research and your long-term professional goals.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
