Clinical Operations Specialist

Job Title: Contract Clinical Operations Lead (COL)

Start Date: 1st September 2025

Contract Length: Initial 6-month contract with potential for extension

Location: Hertfordshire (Hybrid – minimum 2 days per week onsite)

Right to Work: Full UK Right to Work required – sponsorship is not available

Role Overview:

We are currently seeking experienced and highly motivated Clinical Operations Leads (COLs) to support the operational execution of global clinical trials across all development phases. This contract role sits within a leading global pharmaceutical organisation's clinical development function and plays a vital part in advancing innovative treatments and improving patient outcomes worldwide.

As a COL, you will collaborate cross-functionally with global teams to ensure trials are delivered with a strong emphasis on quality, compliance, operational excellence, and patient-centricity. This role demands proactive leadership, critical thinking, and adaptability in a fast-paced, matrixed environment.

Key Responsibilities:

• Design and manage clinical study operational plans, timelines, and budgets.
• Oversee vendor performance, including CROs and central labs, ensuring alignment with study objectives.
• Lead and influence cross-functional global study teams to drive operational delivery.
• Ensure adherence to ICH-GCP guidelines, local regulations, and internal SOPs.
• Support resource planning, site readiness, and clinical supply forecasting.
• Lead feasibility assessments and site selection strategies across multiple geographies.
• Act as the primary operational contact for investigative sites and external stakeholders, promoting engagement and retention.
• Contribute to trial delivery through collaborative communities and global portfolio forums.

Required Qualifications & Experience:

• Minimum 3 years of experience in clinical trial management or a closely related field.
• Proven experience delivering clinical trials in a global or regional setting.
• Strong understanding of drug development processes and regulatory requirements (e.g., ICH-GCP).
• Bachelor’s degree in life sciences or a health-related discipline, or equivalent professional experience.
• Demonstrated ability to lead cross-functional teams in a complex, fast-paced environment.
• Proficient in vendor oversight, issue resolution, and operational planning.
• Available to start by 1st September 2025 and able to commit to a hybrid working model.

Preferred Skills & Attributes:

• Experience managing Phase I–IV global clinical trials.
• Familiarity with clinical systems, metrics tracking, and operational tools.
• Comfortable working across multiple time zones and geographies.
• Strong interpersonal skills with the ability to influence and build relationships with internal and external stakeholders.
• Adaptable, solution-oriented, and capable of navigating ambiguity.
• Prior experience working in large pharmaceutical companies or global CROs is highly desirable.