Global Studies Asset Manager (GSAM)

Roche; Basel; On-site; CHF 120,000 - 180,000; Full time

Job summary

Roche in Basel, Switzerland seeks a Global Studies Asset Manager (GSAM) within Pharma Product Development Global Clinical Operations (PDG). The role ensures consistent global operations for a group of studies, collaborating with internal teams and partner CROs to deliver timely and compliant study execution.

You will lead study management activities, contribute to essential study documents, forecast recruitment, and drive KPI-based performance.

Qualifications

• Undergraduate degree in life sciences or equivalent with relevant operations experience.
• Experience with drug development processes and regulations (ICH/GCP).
• Growth mindset, proactive and collaborative in fast-paced settings.

Responsibilities

• Coordinate and deliver study management for a group of studies within an asset portfolio following ICH-GCP and Roche SOPs.
• Contribute to essential study-level documents (e.g., protocol, TMP, Pharmacy manual).
• Develop recruitment forecasts with APO, Roche countries and CRO partners; maintain forecasts in EFT or equivalent systems.
• Collaborate with CRO partners to develop and maintain study materials (Pharmacy manual, IMP management documents).
• Drive operational innovation in partnerships with COE, APO and HBS to meet industry best practices.
• Foster effective study partnerships with TA-aligned CROs to optimize expertise and resource use.
• Develop and monitor KPIs for areas of responsibility and communicate risks and mitigations.
• Maintain inspection readiness for components under responsibility; oversee vendor selection and oversight.
• Produce, translate, and distribute patient and site-facing materials; manage IMP supply and shipment.
• Provide feedback to team members to support development and a high-performing organization.

Skills

Operations experience

Drug development knowledge

ICH/GCP familiarity

Education

Bachelor's degree in life sciences

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 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.

This role is based onsite at our Basel, Switzerland office.

Who we are

A 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.