Pay & benefits

What you'll get

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

Requirements

What we're looking for

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

Nice to have

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

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

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

The role

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.

What you'll do

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.
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

About BeOne Medicines

BeOne Medicines, formerly known as BeiGene, is a global biotechnology company focused on developing and commercializing innovative cancer treatments. With a mission to make oncology medicines more accessible and affordable worldwide, the company operates across the entire value chain, from research and development to manufacturing and commercialization. BeOne Medicines has a significant global footprint, with teams across North America, Europe, Asia, and other regions, and is recognized as a key player in the oncology space.

In Spain, BeOne Medicines has established a presence to support its clinical development and commercial activities, with roles based in Madrid and Barcelona. The company is actively expanding its operations in Europe, and its Spanish offices contribute to global clinical trials and medical affairs. For international professionals, BeOne Medicines offers an opportunity to work in a fast-paced, science-driven environment with a mission to impact cancer care globally. The company values diversity and collaboration, and its Spanish teams work closely with global counterparts, making it an attractive option for those looking to advance their careers in the biotech industry.

Founded: 2010
Employees: 10,000+
Headquarters: Basel, Switzerland
In Spain: Madrid, Barcelona
Website: https://jobeax.com/link/6HtFq7fJYWSE0C2b

Good to know if you are moving

BeOne Medicines has a global presence with offices in multiple countries, including Spain, offering opportunities for international mobility.
The company is focused on oncology, a high-impact therapeutic area, providing meaningful work for professionals in clinical research and medical affairs.
Spain is a key market for clinical trials, and the company's Spanish offices are involved in global studies, offering exposure to international projects.
The company offers a collaborative and science-driven culture, with a strong emphasis on innovation and patient impact.
As a global biotech, BeOne Medicines provides competitive compensation and benefits, and supports professional development in a growing industry.

In their own words

About the company & team

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.

Additional information

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.

All open roles at BeOne Medicines

Study Start-up Specialist

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