Clinical Operations Lead

Clinical Operations Lead (COL) The Clinical Operations Lead (COL) has responsibility for the delivery of the studies at investigator sites and is an active participant on the Galderma study team(s). The COL works in close collaboration with other Galderma COLs and CRAs, as well as the Global Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. This position may oversee other internal and external Sr. CRA/ CRA activities including vendor CRAs. Location: Field-based Key Responsibilities Acts as a specialized, centralized point of contact for clinical trial investigator sites, focusing on optimizing site selection, activation, and performance throughout the study lifecycle. Ensures quality, compliance, and proactive issue resolution, often managing decentralized capabilities like home health and ePRO, while fostering positive relationships with sites to support Galderma's pipeline. Oversee and coordinate clinical trial set up including being a significant contributor to site identification, selection and set-up; coordinate overall interaction with clinical study sites during trial maintenance; key member of Inspection Readiness task force to prepare sites for audits, monitor and support CRO site management activities to ensure quality and timeliness, manage site closure activities with the CRO. Manage, track and document CRO CRA activities by doing quality control of monitoring reports, tracking on-site visit frequency, review of monitoring metrics and organizing on-site sponsor oversight visits as appropriate; reviews compliance to the study monitoring plan. Establish country and/or site-specific recruitment targets and study deliverables (e.g. RA submissions, Interim Analysis, Database Lock etc) with internal / external CRAs and CPM/ CTMs to meet timelines. In collaboration with study Leadership and CPM/ CTM, participate in CRO and other third-party vendor selection; assist with the review of proposals, attending bid defenses (as required), and set up user acceptance testing (UAT) of systems for the study (e.g. EDC, IRT, central laboratory portals etc). This includes review of relevant vendor documentation (system specifications, validation etc.) and study plans. Ensure quality and compliance with relevant regulatory standards according to procedural documents (i.e., regulatory approvals before initiations), international guidelines such as ICH and GCP as well as relevant local regulations; ensure that appropriate documentation is available to the investigators in a timely manner. Coordinate, organize and deliver training at investigator meetings, and CRO/CRA training meetings; conduct Global and/or Local CRA meetings (as applicable). Track, measure and report to CPM/ CTM any deviations versus planned as well as recruitment; take appropriate steps to ensure recruitment targets are met; collaborate with CPM/CTM to identify issues, trends, resolutions and/or corrective actions. Assist the CPM/ CTM with the preparation of bid grids, budgets and significant study milestones, and hold CROs accountable for contracted tasks relating to monitoring and site quality, while making recommendations for appropriate outsourcing of required functions. Skills & Qualifications Bachelor's degree in Life Sciences or related field required Minimum of 5 years progressive relevant clinical experience in Clinical Operations, including 3 years as Clinical Research Associate or similar role with a pharmaceutical or biotechnology company and/or clinical research organization (CRO) Drug/device combination and biologics experience preferred Ability to manage a phase 1 or small phase 2 clinical trial Excellent knowledge of ICH/GCP, relevant local regulations, basic knowledge of GMP/GDP Solid understanding of the drug development process What We Offer in Return You will be part of an organization that genuinely values and embraces diversity and inclusion. We believe that reflecting the diverse perspectives of our customers leads to stronger, more meaningful outcomes. Next Steps If your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager The final step is a panel conversation with the extended team Our people make a difference At Galderma, you'll work alongside individuals who share your driveas well as those with different perspectives that help us grow. We value the unique contributions of every team member. Our culture of professionalism, collaboration, and support creates an environment where people can truly thrive and excel. Galderma is an equal opportunity employer dedicated to building an inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, genetic information, or any other characteristic protected by applicable law. Galderma is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment.

Created: 2026-03-13