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About the Role

The Clinical Operations Lead (COL) is responsible for the delivery of studies at Investigator sites and actively participates in Galderma study teams. The COL collaborates with other Galderma COLs, CRAs, and the Global Study Team to ensure quality and quantity commitments are met efficiently and on time. This role may oversee internal and external Sr. CRA/CRA activities, including vendor CRAs.

Responsibilities

Acts as a specialized, centralized point of contact for clinical trial investigator sites, optimizing site selection, activation, and performance.
Ensures quality, compliance, and proactive issue resolution, managing decentralized capabilities and fostering positive site relationships.
Oversees and coordinates clinical trial setup, including site identification, selection, and setup.
Coordinates overall interaction with clinical study sites during trial maintenance.
Serves as a key member of the Inspection Readiness task force to prepare sites for audits.
Monitors and supports CRO site management activities to ensure quality and timeliness.
Manages site closure activities with the CRO.
Manages, tracks, and documents CRO CRA activities through quality control of monitoring reports.
Tracks on-site visit frequency and reviews monitoring metrics.
Organizes on-site sponsor oversight visits as appropriate.
Reviews compliance to the study monitoring plan.
Establishes country and/or site-specific recruitment targets and study deliverables.
Collaborates with internal/external CRAs and CPM/CTMs to meet timelines.
Participates in CRO and other third-party vendor selection.
Assists with the review of proposals and attends bid defenses.
Sets up user acceptance testing (UAT) of systems for the study.
Reviews relevant vendor documentation and study plans.
Ensures quality and compliance with regulatory standards, ICH, GCP, and local regulations.
Ensures appropriate documentation is available to investigators in a timely manner.
Coordinates, organizes, and delivers training at investigator meetings and CRO/CRA training meetings.
Conducts Global and/or Local CRA meetings.
Tracks, measures, and reports deviations versus planned activities and recruitment.
Takes appropriate steps to ensure recruitment targets are met.
Collaborates with CPM/CTM to identify issues, trends, resolutions, and/or corrective actions.
Assists the CPM/CTM with the preparation of bid grids, budgets, and significant study milestones.
Holds CROs accountable for contracted tasks relating to monitoring and site quality.
Makes recommendations for appropriate outsourcing of required functions.

Requirements

Bachelor’s degree in Life Sciences or related field required.
Minimum of 5 years progressive relevant clinical experience in Clinical Operations.
Includes 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.
Excellent knowledge of relevant local regulations.
Basic knowledge of GMP/GDP.
Solid understanding of the drug development process.

Skills

Clinical Operations
Clinical Research Associate
ICH/GCP
GMP/GDP
Drug development process
Site selection
Site activation
Site performance optimization
Issue resolution
Decentralized capabilities management
Home health management
ePRO management
Vendor management
CRO management
Monitoring report quality control
Recruitment target setting
Study deliverable management
Bid defense participation
User acceptance testing (UAT)
Regulatory compliance
Training delivery
Data analysis
Risk identification
Corrective and preventive actions (CAPAs)

Location

London, UK

Work Type

Full-time

Experience Level

Minimum of 5 years progressive relevant clinical experience
3 years as Clinical Research Associate or similar role

Education Level

Bachelor’s degree in Life Sciences or related field

About the Company

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.