Study Start Up Lead

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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.

• 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, ensuring regulatory coordination.
• Strategize on Budget ;
  Contracts:
  You will provide strategic oversight for all aspects of budgeting and contract management, including developing budget strategies and negotiating with internal and external stakeholders.
• Influence the Environment:
  You will participate in external industry collaborations to influence the countrys start-up environment.

• You have a degree (MD, PhD, MA/MS, BA/BS) in life sciences or a related field. A postgraduate degree in clinical trials or clinical research is highly desirable.
• You have demonstrated experience in clinical trial start-up in Spain, regulatory submissions, and cross-functional collaboration.
• Proven track record in managing site relationships with a customer centric mindset and managing complex clinical trials start-up (e.g. at least 2-year previous experience as a Clinical Trial Monitor).
• You possess a strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• You have excellent communication, interpersonal, and problem-solving skills, with a collaborative mindset.
• You are fluent in both written and spoken English, and in Spanish.
• Ability to manage multiple priorities and work in a fast-paced, dynamic environment.
• Ability to travel if needed.

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique.

Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

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