Study Start-up Specialist

BeOne Medicines

. Plan, coordinate, and oversee the start-up process of clinical studies, ensuring deadlines and quality standards are met .

Posted 9/24/2026full-timeRemote • SpainJuniorMid-Level💰 €46,100 - €57,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study start-up processes, regulatory compliance, and site management, with a strong focus on quality assurance and effective communication across multilingual environments.

Highest-signal resume keywords

Clinical Study Start-UpRegulatory ComplianceInformed Consent Form ManagementGCP KnowledgeMultilingual Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsRegulatory ProcessesBudget ManagementContract NegotiationQuality ReviewSite File ReconciliationStudy Protocol AmendmentsDocument TranslationSite EvaluationCorrective Action Proposals

Soft Skills

CollaborationProblem-SolvingInnovation PromotionEscalation ManagementCommunication

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft ProjectMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

Pharmaceutical IndustryCRO IndustryICH GuidelinesIVDR StudiesSite PracticesStudy MilestonesCountry RegulationsStudy DocumentationInspection ReadinessRecruitment Materials

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plan, coordinate, and oversee the start-up process of clinical studies, ensuring deadlines and quality standards are met
Collaborate with the Regional Submission Lead to deliver start-up milestones on time
Provide country-specific study start-up expertise and support start-up activities, budget, and contract negotiations
Review, manage, and translate Informed Consent Forms, adapting study templates to country requirements
Retrieve essential documents from study sites and perform essential document site file reconciliation
Conduct independent quality reviews of submission packages and submit packages to EC and HA when required
Review and translate site-specific recruitment materials and other applicable documents
Oversee and execute study protocol amendments throughout the study lifecycle
Ensure inspection readiness of start-up study and site documentation
Evaluate site practices and escalate quality or GCP issues as appropriate
Identify site issues, propose corrective and preventative actions, identify gaps, and promote innovation
Manage and coordinate start-up activities for IVDR studies when required
Notify HAs of study conclusion and other required milestones
Act as escalation point for SSUs regarding site-related issues and concerns
May serve as subject matter expert for clinical operations, country regulations, and SSU-related activities

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Pharmacy, Biomedicine, or a related field (exceptions might be made for candidates with relevant clinical operations experience)
Minimum of 2 years of experience in the pharmaceutical industry, preferably in startup role
Solid understanding of regulatory processes and compliance in clinical research
Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Thorough knowledge of ICH and associated regulatory guidelines
At least 2 years of Start-up experience in the pharmaceutical or CRO industry
Fluent in English, Spanish, and Portuguese (writing and speaking)
Experience working with Portugal is preferred

Benefits

Comp & perks

Equal opportunity employer
Travel might be required as per business need