Study Manager - Clinical Operations

i-Pharm Consulting; Greater London; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading company in rare diseases seeks a Study Manager for a 6-month contract in London. The role involves managing clinical studies, overseeing teams, and ensuring quality and compliance. Ideal candidates will have extensive experience in biopharmaceutical research and vendor management.

Qualifications

• 7+ years in life sciences or related field.
• 4 years in biopharmaceutical clinical research.
• Experience overseeing external vendors (CROs).

Responsibilities

• Oversee overall study execution.
• Manage risks, issues, and communicate updates.
• Collaborate with other Study Managers.

Skills

Decision Making

Problem Solving

Leadership

Data Analysis

Compliance

Education

BA/BS/BSc

Job description

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Senior MSP Consultant at i-Pharm Consulting

Job Title: Study Manager - Clinical Operations

Period - 6 Month Contract

Location - United Kingdom, London (Hybrid)

Inside IR35

Desirable: Experience With Rare Diseases

The company is a leader in delivering therapeutics for serious and life-threatening rare genetic diseases. We focus on conditions that lack effective therapies and affect small patient populations, many of whom are children. Our aim is to improve outcomes for people with rare diseases by advancing therapeutics, care standards, and providing global support.

The Global Study Operations (GSO) function provides strategic direction on clinical studies, driving the delivery of high-quality data for asset registration and approval. This includes developing Clinical Development Plans, study planning, cross-functional leadership, trial expertise, and vendor oversight.

Role Summary:

The Study Manager (SM) is responsible for day-to-day GSO study execution and deliverables. The SM manages risks, issues, and opportunities impacting timelines, quality, and budget, oversees the GSO study team, vendors, and CRO, and collaborates with cross-functional teams. The role involves managing early-stage, late-stage, or post-approval studies, leading Study Execution Team (SET) activities, and facilitating meetings.

Core:

• Decision Making & Problem Solving
• Influence & Organizational Awareness
• Agility & Proactivity
• Leadership

Technical:

• Data Analysis & Interpretation
• Study Management & Execution
• Compliance & Quality
• Drug Development & Study Design
• Product & Therapeutic Area Knowledge

Responsibilities:

• Oversee overall study execution
• Lead and guide GSO staff assigned to studies
• Identify, manage, and communicate risks and issues
• Provide regular quality and progress updates
• Monitor study metrics and take appropriate actions
• Collaborate with other Study Managers for consistency
• Support career growth of Study Specialist staff
• Contribute to protocol and Informed Consent Form (ICF) development
• Manage study timelines, CROs, vendors, lifecycle, budget, and enrolment
• Lead or participate in study-specific projects
• Implement process improvements within the team

Education & Experience Required:

• BA/BS/BSc
• 7+ years in life sciences or related field, including 4 years in biopharmaceutical clinical research
• Experience overseeing external vendors (CROs, central labs, etc.)

If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at [e-mail] or call: [phone]

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research

• Industries

  Research Services and Pharmaceutical Manufacturing

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