Senior Clinical Trials Manager

Orphalan

. Plan, set up, conduct, close out, report on, and archive clinical research trials according to applicable international, local, and company standards .

Posted 11/5/2026full-timeLondon • United KingdomSenior💰 £75,000 - £95,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical research management, ensuring compliance with Good Clinical Practice (GCP) and regulatory standards while delivering high-quality clinical data. Proficient in project management, vendor management, and developing key study documents to support successful trial execution.

Highest-signal resume keywords

Clinical Research ManagementGood Clinical Practice (GCP)Vendor ManagementProject ManagementClinical Study Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ExecutionStudy Performance AnalysisRisk Assessment StrategiesRegulatory ComplianceClinical Study Protocol DevelopmentFinancial AnalysisPatient EnrollmentSite SelectionQuality Control ImplementationScientific Result Interpretation

Soft Skills

Interpersonal Relationship SkillsTeam LeadershipOrganizational SkillsCommunication Skills

Tools & Technologies

ETMFMSAsWOsCTAsTAs

Industry Keywords

Clinical ResearchPharmaceutical IndustryBiotech IndustryRegulatory Authority InspectionsSOP Development

About the role

Key responsibilities & impact

Plan, set up, conduct, close out, report on, and archive clinical research trials according to applicable international, local, and company standards
Lead clinical trial execution to agreed timelines and budgets while ensuring compliance with protocols, Good Clinical Practice, GDPR, SOPs, and local regulations
Plan clinical research activities and align vendors with the internal organization
Deliver high-quality clinical research data and complete study documentation, including the eTMF
Establish effective working relationships with external providers and vendors
Keep the Orphalan organization informed about ongoing trial progress and issues
Collaborate with internal and external stakeholders to deliver successful trial execution
Contribute to periodic financial analyses of costs, invoices, and budgets
Lead the evaluation, selection, and management of third-party vendors, including CROs
Drive operational input into MSAs, WOs, CTAs, and TAs
Partner with CMC/clinical supplies on drug supply assumptions and clinical trial supply design and packaging
Develop and author key study documents, including clinical study protocols, ICFs, CSRs, and other clinical documents
Develop and execute trial risk assessment strategies, document risks, create mitigation plans, and escalate and resolve issues
Support QC implementation, compliance with quality measures, and monitoring of study quality metrics
Provide input on SOP development for clinical operations and companywide procedures

Requirements

What you’ll need

Bachelor or master’s degree in life sciences
At least 10 years’ experience in clinical research
At least 5 years in clinical study management in pharmaceutical or biotech industries
Knowledge and understanding of project management
Experience analyzing study performance indicators, including regulatory approvals, site selection, site initiation, patient enrolment, and patient performance
Ability to interpret scientific results
In-depth knowledge of GCP and current legislation supporting clinical research
Previous participation in regulatory authority inspections/audits
Team-oriented attitude with the ability to steer a team
Strong interpersonal relationship skills
Highly organized and structured personality
Advanced English language skills in writing and speech

Benefits

Comp & perks

Hybrid work arrangement
Willingness to travel abroad/intercontinental as required (3 to 6 times per year)