Study Start-up Specialist

BeOne Medicines Ltd.; España; Presencial; EUR 46.000 - 58.000; Jornada completa

Descripción de la vacante

BeOne Medicines Ltd. is seeking a Startup Specialist to manage and coordinate all start-up activities for clinical trials across multiple sites, ensuring compliance with regulatory and quality standards.

You will collaborate with regional leads, provide country-specific start-up expertise, and manage essential documents, translations, and amendments throughout the study lifecycle.

Formación

• Bachelor's degree in Life Sciences, Pharmacy, Biomedicine, or a related field (exceptions may 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

Responsabilidades

• Plan, coordinate, and oversee the start-up process of clinical studies, ensuring deadlines and quality standards are met
• Provide country-specific start-up expertise and support in budget and contract negotiations
• Review, manage, and translate the Informed Consent Form to country requirements
• Coordinate with investigators and team to obtain essential site documents and reconcile site files
• Perform quality review of submission packages and submit to EC/HA as required
• Translate and adapt site-specific recruitment materials and documents
• Oversee amendments to study protocols and ensure regulatory compliance

Conocimientos

Fluent English

Fluent Spanish

Portuguese language

Educación

Bachelor's degree in Life Sciences/Pharmacy/Biomedicine

Descripción del empleo

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

The Startup Specialist will be responsible for managing and coordinating all activities related to the startup of clinical trials at multiple sites.

This role is crucial to ensure that trials are initiated efficiently and meet regulatory and quality requirements.

Essential Functions Of The Job

• Plan, coordinate, and oversee the start-up process of clinical studies, ensuring that deadlines are met, and quality standards are upheld. Collaborate with the Regional Submission Lead to ensure the timely delivery of start-up milestones.
• Provide country-specific study start-up expertise, assist in start-up activities, and provide support in budget and contract negotiations
• Review, manage, and translate the Informed Consent Form, adapting the Study template to Country requirements.
• Work closely with investigators, physicians, and other research team members to retrieve essential documents from study sites and perform essential document site file reconciliation
• Perform independent quality review of submission packages, submit package to EC (and HA), if required,
• Review and translate site-specific recruitment materials and other applicable documents.
• Oversee and execute amendments to study protocols during the lifecycle of the study, ensuring timely communication and compliance with regulatory requirements.
• Ensure inspection readiness of start-up study and site documentation.
• Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
• Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question the status quo, and promote innovation.
• Manage and coordinate the startup activities specific to In Vitro Diagnostic Regulation (IVDR) studies, ensuring compliance with relevant regulations and standards, if required.
• Notify HAs of the study's conclusion and other required milestones as mandated.

Supervisory Responsibilities

• Acts as the escalation point person for SSUS(s) with site related issues and concerns.
• May serve as subject matter expert for clinical operations, country regulations and SSU-related activities

Education Required

• 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 researc

Computer Skills:

Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Other Qualifications

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• At least 2 years of Start-up experience in the pharmaceutical or CRO industry
• Excellent communication and interpersonal skills
• Fluent in English, Spanish, and Portuguese (writing and speaking)
• Experience working with Portugal is a preferred.

Travel:

Travel might be required as per business need

Salary Range Spain: 46,100.00 EUR - 57,600.00 EUR

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.