Global Studies Asset Manager (GSAM)

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 PositionAt 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 Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.