Clinical Operations Lead - Global

Galderma; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

Galderma is seeking a Clinical Operations Lead to drive study delivery at investigator sites and collaborate with Global Study Teams. The role involves optimizing site activation, monitoring quality, and coordinating CRO activities to meet timelines.

The successful candidate will bring 5+ years in clinical operations, strong ICH/GCP knowledge, and experience with phase 1/2 trials. A Life Sciences degree is required, with potential for cross-functional leadership across studies.

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• Minimum of 5 years progressive relevant clinical operations experience.
• 3 years as CRA or similar role in pharma/CRO.
• Experience with drug/device combinations and biologics preferred.
• Ability to manage a phase 1 or small phase 2 trial.
• Strong knowledge of ICH/GCP and local regulations; GMP/GDP basics.

Responsibilities

• Act as centralized contact for investigator sites, optimize site selection and performance.
• Oversee study setup, site interaction, audits readiness, CRO oversight.
• Quality control monitoring reports, tracking visits, review metrics.
• Set recruitment targets with CRAs and CPM/CTMs; meet timelines.
• Collaborate on vendor selection, review proposals, conduct UAT and study plans.
• Ensure regulatory compliance and timely documentation to investigators.
• Coordinate training at investigator meetings and CRA trainings.
• Track deviations and recruitment, implement corrective actions.
• Assist CPM/CTM with bid grids, budgets, milestones; oversee CRO tasks.

Skills

Clinical Operations

CRA Experience

ICH/GCP Knowledge

GMP/GDP Knowledge

Drug Development

Phase 1/2 Management

Education

Bachelor's degree in Life Sciences

Job description

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