Study Start-up Specialist

🔥 1 minute ago

🇪🇸 Spain – Remote

💵 €46.1k - €57.6k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 1%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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

• 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

• Equal opportunity employer • Travel might be required as per business need