Global Studies Asset Manager; GSAM

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft.

Werde Teil von Roche, wo jede Stimme zählt.

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.

• 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…