Roche
StudyStartUpLead
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“Study Start Up Lead at Roche. Skills: clinical trial start-up, regulatory submissions, cross-functional collaboration, stakeholder management. Lead Country Strategy for study start-up. Oversee start-up operations”
What You'll Achieve.
efficient initiation of clinical trials; deliver innovative treatments to patients; seamless trial execution for patients, investigators, and clinical site staff; timely and efficient site activation; regulatory compliance; improve timelines
Industry & Context.
excellent problem-solving skills
Ability to travel if needed
What They're Looking For.
Must Have
degree (MD, PhD, MA/MS, BAS) in life sciences or a related field, demonstrated experience in clinical trial start-up in Spain, regulatory submissions, cross-functional collaboration, managing site relationships with a customer centric mindset, managing complex clinical trials start-up (e.g. at least 2-year previous experience as a Clinical Trial Monitor), understanding of ICH-GCP, understanding of EU CTR, understanding of local regulatory environments, excellent communication skills, excellent interpersonal skills, excellent problem-solving skills, collaborative mindset, fluent in both written and spoken English, fluent in Spanish, Ability to manage multiple priorities, work in a fast-paced, dynamic environment
Nice to Have
postgraduate degree in clinical trials or clinical research
What You'll Do.
Lead Country Strategy for study start-up
Oversee start-up operations
Drive process improvements
Collaborate with regional and global counterparts
Manage clinical trial submissions
Provide strategic oversight for budgeting
Provide strategic oversight for contract management
Participate in external industry collaborations
How You'll Work.
Team & Collaboration
work in a highly collaborative and cross-functional environment; collaborate with regional and global counterparts; negotiating with internal and external stakeholders
Communication Scope
excellent communication skills; excellent interpersonal skills
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. As a key member of our Country Study Start-Up team, you will drive and facilitate the efficient initiation of clinical trials, ultimately helping to deliver innovative treatments to patients. You will work in a highly collaborative and cross-functional environment, where you have the opportunity to influence and shape our clinical trial delivery strategy. This is a unique opportunity to use your expertise to make a meaningful impact by ensuring seamless trial execution for patients, investigators, and clinical site staff. **The Role** ● Lead Country Strategy: You will lead the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders. ● Oversee Operations: You will oversee start-up operations to ensure timely and efficient site activation and regulatory compliance. ● Drive Process Improvements: You will identify and lead opportunities for process automation, standardization, and innovation at both the country and site levels. ● Collaborate and Harmonize: You will collaborate with regional and global counterparts to harmonize systems and improve timelines. ● Manage Clinical Trial Submissions: You will oversee the development and management of clinical trial submissions and amendments
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