Global Studies Asset Manager (GSAM)

F. Hoffmann-La Roche Gruppe; Welwyn Hatfield; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading pharmaceutical company in Welwyn is seeking a Global Asset Study Manager to oversee the execution of global clinical operations for various studies. The ideal candidate should have relevant operations experience, a strong understanding of drug development processes, and a passion for innovative practices. This role involves collaboration with internal teams and vendor partners to ensure successful study delivery and efficiency.

Qualifications

• Proven relevant operations experience in clinical trials.
• Strong knowledge of ICH and GCP guidelines.
• Ability to thrive in fast-paced and collaborative environments.

Responsibilities

• Execute global operations for clinical studies.
• Coordinate study management and documentation.
• Develop KPIs and maintain inspection readiness.

Skills

Operations experience

Drug development knowledge

Collaboration skills

Innovation mindset

Education

Undergraduate degree in life sciences

Job description

The Position

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.

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 Asset Study Manager (GASM) at Roche/Genentech 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 ASM 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 IHC-GCP and Roche processes in accordance 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)
• Develops 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 (e.g., Pharmacy manual, relevant study plans, relevant training materials such as 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 to deliver outcomes that meet and exceed industry best practices
• Build and role model effective study partnership behaviors and mindsets with TA-aligned CRO partner to maximize the CRO and internal expertise, minimise duplication of work and ensure cost and resource efficiency for studies under responsibility
• Develop and oversee key performance indicators (KPIs, quality and operational) for areas of responsibility using company tracking systems and proactively communicate risks to timelines/quality, with proposed mitigations to the Global Studies Leader
• Maintain inspection readiness of the relevant components in scope of responsibility
• Lead 3rd party vendor selection, vendor identification, setup, oversight and close out to ensure delivery to contract (in line with iCOP strategies and study-level needs)
• Produce, arrange translation & distribute patient and site facing support materials
• Manage supply and shipment of IMP
• Obtain and distribute clinical trial insurance
• Regularly seek and provide feedback to study team members on their performance to support their development and contribute to a High Performing Organization

Who You Are

• You have a proven & relevant operations experience
• You have an undergraduate degree or equivalent years of experience, preferred focus in life sciences
• You possess a strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines
• You are a self-starter who finds passion in achieving successful outcomes
• You want to make a difference and find excitement in innovating practices, products and processes
• You have a growth mindset and are excited about learning through experience
• You feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments

Preferred Qualifications:

• You have prior clinical trial management

This role is based onsite at our Welwyn, United Kingdom office. We have multiple headcounts available for this role. We look forward to your application.

#ClinOps

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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.