Study Manager, Clinical Operations

Job Title: Study Manager, Clinical Operations

Work location: Holborn, London, UK

Contract duration: 6-months contract and a 12-month contract (2 roles available)

Work schedule: Monday - Friday. 37.5 H/W

Pay rate: £420 - £500/day

Determination: Inside IR35

About the Role:

We are seeking two experienced and highly motivated Study Manager, Clinical Operations to join our client's global bio-pharmaceuticals company based in Holborn, London. These roles are integral to the successful execution of clinical studies, ensuring compliance with regulatory requirements and maintaining the highest quality standards as part of a Global Study Operations team.

Responsibilities for the Study Manager, Clinical Operations may include:

• Oversee overall study execution, ensuring timely and quality delivery of study milestones.
• Provide leadership, guidance, and direction to study staff.
• Facilitate and lead cross-functional teams and subteams.
• Collaborate with study members to execute study deliverables.
• Develop and maintain key study plans (monitoring, data management, safety, etc.).
• Oversee study protocol and informed consent form (ICF) development.
• Plan study resources and manage study timelines.
• Ensure effective vendor oversight and study start-up activities.
• Oversee drug/investigational product (IP) management.
• Manage recruitment, enrolment, and monitoring activities.
• Oversee study closeout activities and program-wide initiatives.
• Lead or participate in study-specific projects with broader program impact.

Qualifications:

• Advanced knowledge and experience in study management and execution.
• Proficiency in compliance and quality data analysis.
• Strong understanding of drug development and study design.
• Experience in managing study timelines, budgets, and resources.
• Ability to lead cross-functional teams and collaborate effectively.

Key Competencies:

• Decision Making, Strategic Thinking, and Problem Solving: Ability to make informed decisions, think strategically, and solve problems effectively.
• Influence and Organisational Awareness: Strong influence skills and understanding of organisational dynamics.
• Agility and Pro-activity: Proactive approach and adaptability in a dynamic environment.
• Leadership: Demonstrated leadership skills to guide and motivate study teams.
• Communication and Collaboration: Excellent communication and collaboration skills with cross-functional teams.
• Data Analysis and Interpretation: Proficiency in analysing and interpreting complex data.
• Product and Therapeutic Area Knowledge: In-depth knowledge of product and therapeutic areas.

Application Process:

To apply, please submit your CV outlining your qualifications and experience relevant to this role.

Please note: You must be able to work in the UK without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Jada Kirlew at jkirlew@i-pharmconsulting.com or call: +44 (0)20 7551 0727 (UK) / +31 208 089 982 (NL)