Clinical Trial Manager

Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.

We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.

At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.

Position Summary

The Clinical Trial Manager (CTM) plans and manages overall activities for assigned global clinical trial(s). This includes timelines budgets resources investigational sites vendors and key deliverables. This position ensures compliance with SOPs regulatory requirements and ICH/GCP guidelines and aligns with company strategies and goals.

Essential Functions

Plan and Conduct Clinical Trials

• Partner with cross-functional Clinical Trial Team to ensure all trial deliverables are met according to timelines budget quality standards and operational best practices.
• Work closely with the Clinical Science Experts and Clinical Scientist for the design of the clinical trials.
• Establish project milestones budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager.
• Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines.
• Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks.
• Contribute to the reporting of clinical studies and clinical documentation to regulatory submissions according to plan and in compliance with applicable regulatory requirements international standards and the company quality system throughout the development life cycle
• As applicable provide oversight to Clinical Research Associates and Clinical Trial Administrators assigned to the clinical trial

Manage Contract Research Organizations (CROs) and Functional Service Providers (FSPs)

• Collaborate with Procurement to prepare clinical outsourcing specifications.
• Participate in the selection of the CRO or FSPs.
• Serve as the primary trial contact with the CRO and FSPs.

Quality and Process

• Ensure that all aspects of the trial are prepared for regulatory inspections at any time.
• Serve as member of the inspection readiness team in preparation of a regulatory inspection.
• Support the preparation for and conduct of investigational site and sponsor health authority inspections as applicable.
• Contribute to and initiate trial and departmental process improvement initiatives.

Minimum Education Knowledge Skills and Abilities

University degree required in Life Sciences such as biology pharmacology nursing or health sciences

• Experience in clinical research/operations (5-7years) or equivalent with Pharma/Biotech and/or CRO experience
• Experience from all parts of the clinical trial process from protocol development to the compilation of study reports
• Experience in supervising CROs.

Excellent understanding of the drug development process systemic drug and biologics experience preferred

Excellent knowledge of international ICH/GCP guidelines basic knowledge of GMP/GDP

Excellent knowledge of relevant local regulations

• Fluent in English (written and oral)

Working Conditions & Physical Requirements

The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing duties of this job the employee may or may not be frequently/or occasionally required to:

• Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
• Climb stairs or ride elevators.
• Lift and/or move up to 25 pounds.
• Use close vision distance vision peripheral vision depth perception and ability to adjust focus.
• Manipulate keyboard or otherwise access computer telephone and hand-held devices.
• Be exposed to outside weather conditions while going in and out of office buildings.
• Be exposed to moderate noise level usually in warehouse settings.
• Be exposed to moving equipment mechanical parts and/or high places; or moving between air-conditioned and non-air-conditioned environments.
• Willingness to travel for internal corporate and external investigator and scientific meetings both nationally and internationally. Travel estimated at 20%.