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 body's 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.
Job Title: Clinical Operations Lead
Location: London, UK
Job Summary
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.
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. May utilize data tools to monitor site performance, proactively identify risks, and implement corrective and preventive actions (CAPAs) 20%
- 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 10%
- 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 onsite sponsor oversight visits as appropriate; reviews compliance to the study monitoring plan 10%
- 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 15%
- 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 10%
- 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 10%
- Coordinate, organize and deliver training at investigator meetings, and CRO/CRA training meetings; conduct Global and/or Local CRA meetings (as applicable) 10%
- 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. 10%
- 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 5%
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
