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Die Position

At Roche 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.

PD’s mission is to improve patients’ lives around the world through unique medicines that have a meaningful impact. Cross functionally we conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients. Our primary disease focus areas are Oncology, Hematology, Neurology, Immunology, Ophthalmology, Cardiovascular, Renal,and Metabolism (CVRM). We attract, develop, and retain the most talented people in the industry, within PDG’s Clinical Operations Country Footprint.

The Global Studies Asset Manager (GSAM) is responsible for the consistent and efficient execution of global operations for a group of studies related to an asset, or within a Disease Area (DA) or Therapeutic Area (TA). This role involves working closely with internal teams and partner operations, as well as cross-functional experts and vendor partners, to ensure smooth operational delivery. As a vital member of the Extended Study Management Team (SMT), the GSAM provides operational delivery expertise to ensure consistency and efficiency across the assigned studies.

The Opportunity

• Co-ordinate and deliver the study management aspects of a group of studies within an asset’s portfolio following ICH-GCP and Roche processes in accordance with SOPs and guidelines to ensure the clinical study progresses as planned
• Provide input into the development of essential study level documents (e.g. study protocol, TMP, Pharmacy manual).
• Develop a study's recruitment expectations in partnership with APO, Roche countries and the partner CRO and develops and maintains a forecast using the appropriate systems (EFT)
• Develop and/or maintain or provide input in collaboration with CRO partners, study management essential documents (EG Pharmacy manual, relevant study plans/ relevant training materials (EG IMP management))
• Drive innovation in clinical operations by thinking of and contributing to the implementation of new approaches in partnership with COE, APO and HBS in order to deliver outcomes that meet and exceed industry best practices.
• Build and role model effective study partnership behaviors and mindsets with your TA aligned CRO partner to ensure we maximize the expertise of the CRO and our internal colleagues, minimising duplication of work and ensuring cost and resource efficiency for study(ies) in responsibility
• Develop and oversee key performance indicators (KPIs, quality and operational) for areas of responsibility by using company tracking systems and proactively communicating any risks to timelines and/or quality, or identified quality issues, along with proposed mitigations to your Global Studies Leader
• Maintain inspection readiness of the relevant components in scope of responsibility
• Lead 3rd party vendor selection, setup, oversight, and closeout to ensure delivery to contract (in line with relevant iCOP strategies and study level needs)
• Produce, arrange translation & distribute patient and site facing support materials
• Manage supply and shipment of IMP
• Regularly seek and provide feedback to study team members on their individual performance to support their professional development and contribute to the achievement of a High Performing Organization.

Who You Are

• Hold an undergraduate degree or equivalent experience (preferably focused in life sciences), backed by proven and relevant operations experience, a strong working knowledge of drug development processes and regulations (including ICH/GCP guidelines). Clinical trial management experience is preferred.
• Act as a results-driven self-starter passionate about making a difference, achieving successful outcomes, and discovering excitement in innovating practices, products, and processes.
• Have a growth mindset with an eagerness to learn through experience, are comfortable thinking on your feet, and thriving within fast-paced, ambiguous, and highly collaborative environments.

Ready to Apply?

We would love to hear from you! Please click "Apply Now" to submit your application. To help us get to know you better, please make sure to upload: Curriculum Vitae, Cover Letter, and copies of your relevant Diplomas / Academic Certificates This role is based onsite at our Basel, Switzerland office.

#ClinOps

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

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