Global Clinical Study Lead (Switch)

Opella; Neuilly-sur-Seine; Sur place; EUR 110 000 - 140 000; Plein temps

Résumé du poste

Opella is accelerating self-care innovation and is looking for a Global Clinical Study Lead to drive planning, execution and delivery of global clinical and evidence generation studies across OTC, VMS and Rx-to-OTC portfolios.

You will partner with cross-functional teams and external partners to ensure studies are on time, within budget, and compliant with quality standards while advancing evidence generation in self-care.

Qualifications

• Bachelor's degree in a scientific discipline (advanced degree preferred).
• 8+ years of clinical study management experience within Pharma, Consumer Healthcare and/or CRO environments.
• Strong project management and vendor management experience.
• Proven experience overseeing outsourced studies from start-up through reporting and eTMF completion.
• Experience in Consumer Healthcare and/or Rx-to-OTC switch programs is a strong advantage.
• Solid knowledge of ICH-GCP and international clinical research standards.

Responsabilités

• Lead end-to-end delivery of global clinical and evidence generation studies.
• Ensure achievement of study milestones, timelines, budgets and quality objectives.
• Oversee study activities from planning through close-out and archiving.
• Lead cross-functional collaboration across Medical, Regulatory, Safety, Quality, Procurement and Legal teams.
• Manage CROs and external partners, ensuring high-quality delivery and performance.
• Deliver studies supporting OTC, VMS and Rx-to-OTC switch programs, including actual use and human factors studies.
• Partner with Medical and Regulatory teams to align evidence generation with business and market needs.
• Ensure compliance with ICH-GCP, applicable regulations and internal SOPs.
• Maintain inspection readiness and oversight of study documentation, including eTMF management.
• Identify opportunities to improve study processes, efficiency and innovation.
• Contribute to best practices and capability building across the Clinical Evidence organization.

Connaissances

Project management

Vendor management

Clinical study oversight

Regulatory compliance

Cross-functional collaboration

Formation

Bachelor's degree in science

Advanced degree preferred

Description du poste

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a Global Clinical Study Lead, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

About The Job

At Opella, we’re reinventing self-care through science-driven innovation. As a Global Clinical Study Lead, you will lead the planning, execution and delivery of global clinical and evidence generation studies that support our OTC, VMS and Rx-to-OTC switch portfolios.

You will work with cross-functional teams and external partners to ensure studies are delivered on time, within budget and in compliance with quality and regulatory standards, while contributing to the evolution of evidence generation in self-care.

• Lead initiatives that advance our brands and strengthen our reputation worldwide.
• Mentor and uplift emerging talent while pushing your own growth and influence.
• Put purpose into practice - embedding sustainability, access and social impact into every decision.
• Model the challenger mindset: question complexity, act with integrity and make things radically simple.
• Help shape a culture that’s ambitious, collaborative and serious about recognition and belonging.

Main Responsibilities

Lead Clinical Studies

• Manage end-to-end delivery of global clinical and evidence generation studies.
• Ensure achievement of study milestones, timelines, budgets and quality objectives.
• Oversee study activities from planning through close-out and archiving.

Drive Collaboration & Vendor Management

• Lead cross-functional collaboration across Medical, Regulatory, Safety, Quality, Procurement and Legal teams.
• Manage CROs and external partners, ensuring high-quality delivery and performance.

Support Self-Care & Switch Evidence Generation

• Deliver studies supporting OTC, VMS and Rx-to-OTC switch programs, including actual use, self-selection, label comprehension and human factors studies.
• Partner with Medical and Regulatory teams to align evidence generation with business and market needs.

Ensure Quality & Compliance

• Ensure compliance with ICH-GCP, applicable regulations and internal SOPs.
• Maintain inspection readiness and oversight of study documentation, including eTMF management.

Drive Continuous Improvement

• Identify opportunities to improve study processes, efficiency and innovation.
• Contribute to best practices and capability building across the Clinical Evidence organization.

Qualifications

About You

• Bachelor's degree in a scientific discipline (advanced degree preferred).

Experience

• 8+ years of clinical study management experience within Pharma, Consumer Healthcare and/or CRO environments.
• Strong project management and vendor management experience.
• Proven experience overseeing outsourced studies from start-up through reporting and eTMF completion.
• Experience in Consumer Healthcare and/or Rx-to-OTC switch programs is a strong advantage.
• Solid knowledge of ICH-GCP and international clinical research standards.

Core Competencies

• Strategic & Business Acumen
• Judgement & Decision Making
• Collaboration & Influence
• Leadership & Change Management
• Ownership & Results Orientation
• Learning Agility

This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you.

We are challengers. We are Opella.

Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds.

About Us

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide - and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more at www.opella.com.