Country Study Manager

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

The Clinical Study Manager is a strategic and operational role within the Medical Cluster, accountable for providing local clinical operations expertise and leadership on assigned medical affairs projects and programs: Funded & Managed Non Interventional studies (NIS), Investigator-initiated studies (lIS), Real World Evidence Scientific Programs (RWE SP) and Compassionate Use Program (CUP), Post Trial Assess Program (PTAP). This role also leads RACE (Review, Assess, Classify,Execute) classifying any type of data collection and supporting the squads. The Clinical Study Manager is also a key contributor to the strategic planning for the assigned studies and projects and implementation and delivery of the assigned medical affairs programs, to Roche’s quality standards, timelines and budget commitments.

The Opportunity:

• Works as a trusted partner to inform, lead and recommend how to operationalize / support Funded/ Managed Non-interventional studies (NIS), Investigator-initiated studies (IIS), Real World Evidence Scientific Projects (RWE SP) and Compassionate Use Programs (CUP)/Post Trial Access Program (PTAP).

• Ensures study adherence to applicable regulatory requirements and Roche procedural documents (ICH GCP/GVP/GPP). Maintains inspection readiness and ensures completion of corrective and preventive actions following audits or inspections.

• Oversees development and maintenance of essential study operational plans and systems including site selection and monitoring plans, study tracking systems, vendor oversight plans and RBQM or equivalent risk management activities. Tracks and reports study metrics.

• Accountable for vendor-related study deliverables including selection, oversight and performance management of vendors, ensuring delivery according to timelines, quality standards, operational procedures and budget.

• Maintains study budgets, approves invoices and monitors financial performance. Identifies budget variances and implements mitigation actions. Supports negotiation of work orders and study agreements when applicable.

• Supervises study feasibility assessments and site selection processes. Manages relationships with study sites to ensure efficient study conduct and recruitment.

• Oversees study activities from site activation through study close-out including monitoring oversight, training of study stakeholders and ensuring proper completion of all study closure activities.

• Ensures submission and tracking of Health Authority and Ethics Committee approvals as required.

• Oversees clinical drug supply management in collaboration with Clinical Drug Supply teams and ensures timely resolution of supply issues.

• When applicable, supports or leads operational coordination across affiliates, including participation in operations team meetings, development of recruitment strategies and alignment with the global study leader.

• Ensures proper handling of all study close-out activities including site close-out, final drug accountability, safety reconciliation and archiving of essential study documentation.

• Show leadership skills through leading successful study teams through all stages of clinical studies

• Contribute to strategic awareness embedded contingencies and risk management mindset

• Responsible for processes and process flows for the assigned studies and responsible for the implementation of these studies in a correct and structured manner in accordance with Polish laws and regulations, global and local SOPs

• Key contributor, in collaboration with local Project Lead/Local Scientific Projects in the planning, execution and delivery of NIS, IIS, CU/PAA/PTA, and RWD portfolio. Proactively communicates status, issues and proposed solutions to relevant stakeholders for the assigned studies.

• In conjunction with Project Lead/Local Scientific Responsible ensures relationships with key sites and collaborative groups are optimized to ensure efficient and smooth conduct of the assigned studies.

• Participates in relevant networks, both local and global.

• Maintains and operates relevant systems, both local and global.

• Demonstrates flexibility to support the business overall in relation to studies and projects

• Co-Leads RACE ((R-eview, A-ssess, C-lassify, E-xecute)

 

Who you are:

Skills and experience:

• Project Management: Handling the dynamic cycle of planning, leading, identification, analysis, risk response, monitoring, complex budget and control of the study/project.

• Communication: excellent written and verbal communication skills demonstrated by the ability to present clear messages from complex information/data to all levels in the organization. Clear and accurate communication in written and spoken English.

• Personal Organization: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven.

• Good knowledge of ICH GCP, GPP, Roche SOPs/Guidelines and quality standards related to study management.

• Clinical development experience on the operational aspects of conducting clinical studies and projects.

• Experience of influencing and negotiating at all levels to achieve team delivery.

• Demonstrated ability to interact with different professional levels of the research community.

• Ability to learn new systems.

• Maintain oversight and navigate in updated guidelines and processes.

Competencies:

• Strategic Planning - obtains information and identifies key issues and relationships relevant to achieving a long-range goal.

• Building Partnerships - develops and leverages relationships within and across work groups to achieve results.

• Execution -ensures others contribute to organization strategies by focusing them on the most critical priorities, measures progress, and ensures accountability against those metrics.

• Business Acumen - uses own knowledge of economic, financial, market, and industry trends to understand and improve individual, work group, and/or organizational results; uses own understanding of major business functions, industry trends, and own organization’s position to contribute to effective business strategies and/or tactics.

• Building Networks - takes action to establish and maintain connections with people outside the formal work group, including those outside the organization (e.g., peers, cross-functional partners, and vendors) who are willing and able to provide the information, ideas, expertise, and/or influence needed to achieve work goals.

Other:

• Availability to travel domestically and internationally if required

Apply directly and join us in shaping the future of healthcare.

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The controller of your personal data is Roche Polska Sp. z o.o., ul. Domaniewska 28, 02-672 Warsaw. The data is processed for the purpose of recruitment. You have the right to access your data, rectify it, delete it, limit processing, transfer it and - if processing is based on your consent - withdraw this consent at any time. Contact the Data Protection Officer at: Ochrona.danych@roche.com. More information on the principles of processing your personal data by Roche at the link:  

 https://www.roche.pl/pl/content/klauzula-informacyjna-rekrutacja-en.html

Roche Polska sp. z o.o.  operates in full compliance with the law and does not tolerate any violations. Roche  Polska sp. z o.o.  has implemented a Procedure for Reporting Violations of Law. If you wish to report any irregularities related to our activities, all necessary information regarding the reporting process can be found on our website: https://www.roche.pl/kontakt/ochrona-sygnalistow-zglaszanie-naruszen.

Compensation & Benefits

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Warsaw. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Information about the compensation package for this position will be provided ahead of any interview

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.