Clinical Research Lead

Summary: This Clinical Research Leader role involves leading and supporting multiple clinical trials within the Clinical R&D Department, while building strong relationships across the organization. The position requires oversight of the full study lifecycle and collaboration with various stakeholders to ensure compliance and timely delivery of projects. The leader will also be responsible for developing key study documents and managing trial materials and budgets. This role operates with a high level of independence and requires effective communication of project updates and risks to stakeholders.

Key Responsibilities:

• Lead and manage company-sponsored clinical trials to meet timelines, milestones, and compliance requirements
• Oversee full study lifecycle (feasibility, site selection, startup, conduct, closeout) per ICHGCP, regulations, and SOPs
• Act as primary site contact and collaborate with sites, IRBs/ECs, vendors, and internal teams
• Develop key study documents (protocols, ICFs, CRFs, monitoring plans, reports, investigator brochures)
• Ensure trial registration, results reporting, and support publications
• Manage investigational products, trial materials, site contracts, and payments
• Review clinical data and support statistical analysis and publication readiness
• Perform or support monitoring visits and on-site protocol/data collection activities as needed
• Contribute to literature review, data interpretation, and evidence dissemination
• Deliver projects on time, within budget, and in compliance through cross-functional leadership
• Communicate project updates, risks, and opportunities to stakeholders and leadership
• Track and manage study budgets and resources efficiently
• Support regulatory interactions and clinical strategy discussions
• Maintain knowledge of pipeline, products, and business needs
• Ensure compliance with all applicable regulations, policies, and procedures
• Operate with a high level of independence, making decisions with minimal oversight

Key Skills:

• Experience in leading clinical trials
• Strong knowledge of ICHGCP, regulations, and SOPs
• Excellent communication and collaboration skills
• Ability to develop key study documents
• Experience in managing trial materials and budgets
• Strong analytical skills for data review and statistical analysis
• Ability to operate independently and make decisions
• Knowledge of regulatory interactions and clinical strategy

Salary (Rate): £52.50 hourly

City: Irvine

Country: United States

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

JOB SUMMARY*

This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES*

* Lead and manage company-sponsored clinical trials to meet timelines, milestones, and compliance requirements

* Oversee full study lifecycle (feasibility, site selection, startup, conduct, closeout) per ICHGCP, regulations, and SOPs

* Act as primary site contact and collaborate with sites, IRBs/ECs, vendors, and internal teams

* Develop key study documents (protocols, ICFs, CRFs, monitoring plans, reports, investigator brochures)

* Ensure trial registration, results reporting, and support publications

* Manage investigational products, trial materials, site contracts, and payments

* Review clinical data and support statistical analysis and publication readiness

* Perform or support monitoring visits and on-site protocol/data collection activities as needed

* Contribute to literature review, data interpretation, and evidence dissemination

* Deliver projects on time, within budget, and in compliance through cross-functional leadership

* Communicate project updates, risks, and opportunities to stakeholders and leadership

* Track and manage study budgets and resources efficiently

* Support regulatory interactions and clinical strategy discussions

* Maintain knowledge of pipeline, products, and business needs

* Ensure compliance with all applicable regulations, policies, and procedures

* Operate with a high level of independence, making decisions with minimal oversight

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com