Regional Director of Clinical Operations (West Coast) - Remote

M3 Wake Research; Dallas (TX); Remote; USD 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

401(k), 401(k) matching

Dental insurance

Disability insurance

Employee assistance program

Flexible spending account

Health insurance

Life insurance

Paid time off

Vision insurance

Zusammenfassung

M3 Wake Research is hiring a Regional Director to lead clinical operations across a region of our site network. You’ll oversee Site Directors and Site Managers, partner closely with principal investigators, and ensure enrollment, quality, and revenue goals are met.

This is a remote leadership role with significant travel to sites. Ideally, you bring 7–10+ years in clinical research or related operations and 5+ years of people management, plus strong knowledge of FDA regulations and ICH-GCP.

Qualifikationen

• Bachelor’s degree in science, nursing, or related field.
• 7-10+ years of progressively responsible experience in clinical research or related operations.
• 5+ years of people management experience.
• Clinical experience across two or more therapeutic areas.
• Strong knowledge of FDA regulations, ICH-GCP, safety reporting, and investigational product handling.
• Experience with multi-site networks, SMOs, TMOs, or hospital-owned physician networks

Aufgaben

• Lead, coach, and develop Site Directors and Site Managers, setting clear goals, KPIs, and expectations.
• Step in as Interim Site Director, or arrange solid coverage, when a site is in transition.
• Monitor site operations and performance metrics to improve efficiency, quality, enrollment, and protocol compliance.
• Roll out network-wide processes, systems, and SOPs consistently across your sites.
• Partner with site leadership on budgeting, forecasting, FTE planning, and margin management.
• Review financial and operational reports to spot risks and trends early.
• Work with Marketing and Participant Recruitment to strengthen enrollment strategy and forecasting.
• Support BD with feasibility input and site capability assessments.
• Work with Quality, Regulatory, and Clinical Affairs on audit readiness and PI oversight.
• Build strong relationships with PIs and serve as the regional escalation point for investigator and sponsor concerns.
• Support hiring, onboarding, and staffing decisions for site-level teams.
• Lead mid-year and annual performance reviews for your direct reports

Ausbildung

Bachelor’s degree in science, nursing, or related field

Jobbeschreibung

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Due to our continued growth, we are hiring for a Regional Director of Clinical Operations at Wake Research, an M3 company. This is a remote role with up to 50% travel.

Job Description

M3 Wake Research is looking for a Regional Director to lead clinical operations across a region of our site network. You’ll oversee Site Directors and Site Managers, partner closely with principal investigators, and make sure each site hits its enrollment, quality, and revenue goals. This is a hands-on leadership role for someone who enjoys building accountable teams and keeping trials running smoothly.

Responsibilities

• Lead, coach, and develop Site Directors and Site Managers, setting clear goals, KPIs, and expectations
• Step in as Interim Site Director, or arrange solid coverage, when a site is in transition
• Monitor site operations and performance metrics to improve efficiency, quality, enrollment, and protocol compliance
• Roll out network-wide processes, systems, and SOPs consistently across your sites
• Partner with site leadership on budgeting, forecasting, FTE planning, and margin management
• Review financial and operational reports to spot risks and trends early
• Work with Marketing and Participant Recruitment to strengthen enrollment strategy and forecasting
• Support BD with feasibility input and site capability assessments
• Work with Quality, Regulatory, and Clinical Affairs on audit readiness and PI oversight
• Build strong relationships with PIs and serve as the regional escalation point for investigator and sponsor concerns
• Support hiring, onboarding, and staffing decisions for site-level teams
• Lead mid-year and annual performance reviews for your direct reports

Qualifications

• Bachelor’s degree in science, nursing, or a related field (equivalent combination of education, experience, and training considered)
• 7-10+ years of progressively responsible experience in clinical research or related operations
• Prior experience managing teams or site operations; 5+ years of people management preferred
• Clinical experience across two or more therapeutic areas
• Experience with multi-site networks, SMOs, TMOs, or hospital-owned physician networks preferred
• Strong knowledge of FDA regulations, ICH-GCP, safety reporting, and investigational product handling
• Healthcare background in a line of business with direct patient care and physician collaboration
• Comfortable making financially sound, defensible business decisions
• Strong communicator across sites, sponsors, CROs, and regulators
• Data-driven, with a track record of developing and coaching talen

Additional Information

About M3:

M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.

Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.

Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.

Benefits

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

*M3 reserves the right to change this job description to meet the business needs of the organization