Clinical Lead

RBW Consulting; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

RBW Consulting is seeking an experienced Clinical Lead to drive multi-regional clinical studies. You will serve as the clinical operational lead, guiding project teams and ensuring high standards in site management and monitoring across regions.

Collaborating with Project Managers, CRAs, and sponsors, you will mitigate risks and ensure milestones are achieved while mentoring clinical staff and contributing to strategic study direction.

Qualifications

• Significant experience in clinical monitoring within CRO/biotech/pharma
• Experience in site management across multi-regional studies is preferred
• Strong English communication and stakeholder management skills

Responsibilities

• Provide leadership to clinical teams across multi-regional studies.
• Act as the clinical operational lead to ensure milestones are met.
• Coordinate with PMs, CRAs and sponsors to drive study progress.
• Oversee feasibility, site identification, and study start-up activities.
• Assist with regulatory submissions and IP management.

Skills

Clinical Monitoring

Site Management

Job description

Permanent | Competitive Salary + Benefits

Our client is an established and growing clinical research organisation supporting sponsors across global and multi-regional clinical studies. With a strong reputation for quality, collaboration, and operational excellence, they partner with biotech and pharmaceutical companies to bring innovative therapies to patients worldwide.

The business fosters an inclusive and supportive culture where employees are empowered to contribute, develop their careers, and make a meaningful impact on clinical research.

The Opportunity

We are seeking an experienced Clinical Lead to play a key role in the successful delivery of multi-regional clinical studies. Acting as the clinical operational lead, you will provide direction and oversight to project teams, ensuring site management and monitoring activities are delivered to the highest standard.

Working closely with Project Managers, CRAs, sponsors, and cross-functional teams, you will drive study progress, mitigate risks, and ensure operational milestones are achieved. This role offers the opportunity to combine hands-on clinical expertise with leadership responsibilities, helping to guide and mentor clinical teams while contributing to the overall success of complex clinical programmes.

Key Responsibilities

Clinical Leadership & Study Delivery

• Provide leadership, guidance, and support to clinical teams across multi-regional studies.
• Act as the primary clinical operational lead, ensuring studies remain on track and key milestones are achieved.
• Partner with Project Managers to identify risks, develop mitigation strategies, and drive project success.
• Provide regular updates on study progress, site performance, and operational activities.

Site Management & Start-Up

• Lead and coordinate feasibility assessments, site identification, and site selection activities.
• Oversee site management and monitoring activities, ensuring consistency and quality across study sites.
• Support study start-up activities, including ethics and regulatory submissions.
• Track approvals and timelines to ensure efficient study progression.

Regulatory & Investigational Product Management

• Support regulatory submissions and approvals across multiple regions.
• Assist with Investigational Product (IP) import/export applications, permits, and licences.
• Coordinate with internal teams and vendors to facilitate initial IP distribution and study readiness.

Stakeholder & Sponsor Management

• Act as a key liaison between project teams, sponsors, and internal stakeholders.
• Participate in sponsor meetings, providing clinical and operational expertise.
• Prepare agendas, meeting materials, minutes, and follow-up actions.
• Build strong working relationships with sponsors, maintaining clear and proactive communication throughout the study lifecycle.

Team Development

• Mentor, coach, and support Clinical Research Associates and wider clinical operations teams.
• Lead internal meetings, promoting best practices and operational excellence.
• Contribute to training initiatives and the continuous development of clinical staff.

Requirements

• Significant experience in clinical monitoring and site management within a CRO, biotech, or pharmaceutical environment.
• Strong understanding of ICH-GCP, clinical trial regulations, and study conduct requirements.
• Previous experience leading or mentoring CRAs and clinical project teams.
• Excellent organisational, problem-solving, and stakeholder management skills.
• Strong written and verbal communication skills in English.
• Ability to manage multiple priorities within a fast-paced, global clinical research environment.
• Experience supporting multi-regional or global clinical studies.
• Previous experience in a Clinical Lead, Lead CRA, Senior CRA, or equivalent leadership position.
• Experience with study start-up, regulatory submissions, and investigational product management.

Why Join?

• Join a respected organisation delivering innovative clinical research programmes globally.
• Take on a visible leadership role with the opportunity to influence study strategy and delivery.
• Work alongside experienced clinical professionals in a collaborative environment.
• Benefit from flexible working arrangements that support work-life balance.
• Access ongoing training, professional development, and career progression opportunities.
• Be part of a culture that values inclusion, wellbeing, and continuous improvement.

What Makes This Opportunity Stand Out?

• High level of visibility and influence across global clinical programmes.
• Genuine opportunity to lead and develop clinical teams.
• Combination of operational oversight, sponsor interaction, and strategic study involvement.
• Strong career development potential within a growing and collaborative organisation.