Study Manager

Job Description – Study Manager (pRED)

Contract Type: 6-month contract (Inside IR35, Umbrella)

Location: Hybrid – 3 days per week on-site in Hertfordshire

Start Date: 22nd September 2025

About the Role

We are seeking an experienced Contract Study Manager to join pRED organisation on a 6-month contract. The successful candidate will be responsible for the operational delivery of clinical studies, ensuring they are executed to the highest quality standards, within budget, and in alignment with ICH-GCP and regulatory requirements.

This is a hands-on position suited to professionals who thrive in fast-paced, cross-functional environments and have a strong track record in vendor oversight and study execution.

Key Responsibilities

• Lead and manage the day-to-day operations of assigned clinical studies (Phase I–II focus desirable)
• Ensure compliance with ICH-GCP, internal SOPs, and regulatory guidelines
• Oversee and coordinate vendors, CROs, and external partners to ensure quality delivery
• Manage study timelines, risks, budgets, and issue resolution to enable successful execution
• Contribute to the development of study protocols, study plans, and operational documents
• Represent Clinical Operations in cross-functional global study teams
• Provide oversight of monitoring activities, data collection, and site performance
• Support inspection readiness and contribute to audit responses when required

Essential Requirements

• Prior experience as a Study Manager (or equivalent) in pharmaceutical, biotech, or CRO setting
• Strong knowledge of drug development processes, ICH-GCP, and regulatory requirements
• Proven ability in vendor oversight, risk management, and study operations
• Experience working in global, cross-functional study teams
• Degree in Life Sciences or equivalent professional experience

Preferred Qualifications

• Early-phase (Phase I–II) clinical study management experience
• Advanced degree in Life Sciences
• Exposure to patient-centric trial design and innovative study approaches

Candidate Profile

We are looking for experienced, execution-focused Study Managers with strong operational expertise. Successful candidates will demonstrate:

• Ability to work independently and collaboratively in a complex, global environment
• Strong problem-solving, adaptability, and communication skills
• A hands-on mindset, comfortable managing study execution in detail

Who We Are Not Looking For

• Candidates without direct study management experience
• Profiles from purely academic or research backgrounds
• Junior candidates (CTA, CRA without Study Manager progression)
• Overqualified senior leaders seeking strategic rather than operational involvement
• Candidates unable to commit to hybrid working (3 days per week)