Global Study Manager

ICON plc • Blue Bell, SD

1d • Remote

About The Position

Global Study Manager - Oncology - Home Based ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. Global Study Manager End-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams. This position within GCD is accountable for planning and leading the delivery of oncology studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds. The role may span oncology assets from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. This role is highly visible within Global Clinical Operations.

Requirements

• Bachelor’s degree in life sciences or related discipline.
• Considerable clinical development experience that is equivalent to 3 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
• Proven operational experience of leading high performing global study teams in Oncology clinical trials.
• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
• Strong leadership, influencing and negotiation skills.
• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.

Nice To Haves

• Proven clinical development experience across all phases of development (I-IV).
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary.
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams
• Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value.

Responsibilities

• Lead the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc).
• Drive assessment, selection, engagement, and management of appropriate vendors.
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and client SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
• Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
• Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
• Lead / support the conduct of investigator meetings and other study related meetings

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior