Medical Affairs Clinical Operations Lead

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.

Role Purpose

• The Medical Affairs Clinical Operations Lead (MA COL) is a strategic leadership role within Medical Affairs, accountable for providing local clinical operations leadership and expertise on affiliate executed medical affairs programs including Non-Interventional studies (NIS), investigator-initiated studies (IIS), Compassionate Use and related patient supply programs (CUP, post-trial / approval access), Real World Data program (RWD) and PDMA/LMA projects/ portfolio, as required. The MA POL is also a key contributor to the strategic planning, implementation and delivery of assigned medical affairs programs, to Roche's quality standards, timelines and budget commitments. 

• Acting as Country Study Manager (CSM) for operational delivery of assigned clinical studies through all phases and sponsor types of study management (feasibility, study start-up, conduct, close-out), and RWE scientific projects through partnering with RWD Scientists, in accordance with Roche quality standards, all applicable regulations, timelines and budget commitment. 

• Support to oversee clinical studies that are managed by Clinical Research Organization (CRO) and maintain rapport with site personnels. 

• Ensure capabilities around clinical trial and real-world study operations and provide timely support to affiliate Medical Affairs. 

Role scope:

• As a strategic local Medical Affairs (MA) clinical operations expert, this role is responsible for understanding and assessing the operational opportunities, feasibility and implications for MA's evidence-generation strategies and global MA commitments. 

• Works as a trusted partner to inform, influence and recommend how to operationalise/support the assigned programs, including but not limited to Non-Interventional studies (NIS), Investigator-initiated studies (IIS), Compassionate Use and related patient supply programs (CUP, post-trial / approval access), Real World EvidenceScientific project (RWE SP) and PDMA/LMA projects/ portfolio, as required. 

• Accountable for clinical operations for responsible trials including feasibility, planning, execution, accurate financial and resource planning for MA portfolio by collaborating with PDG, the affiliate MA, RWD Scientists,Financial Controller and Resource Manager, as required. 

• Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO management regarding feedback on CRO staff performance as required. 

• Participates in appropriate and approved local and/or global functional initiatives. 

Requirements:

Qualifications: 

• University Degree or equivalent preferably in a medical / science-related field. Recommended at least 1 years experience in Clinical Research/ Development or related industry. Experience in managing vendors. Previous line management experience / supervision of staff (in applicable). 

Competencies: 

• Technical Professional Knowledge and Skills- has achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results. 

• Adaptability- maintains effectiveness when experiencing major changes in work responsibilities or environment (e.g. people, processes, structure, or culture); adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful. 

• Communication- conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others. 

• Decision Making- identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences. 

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

• Planning and Organizing Work- establishes an action for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources. 

• Building Customer Relationships- ensures that the customer's internal or external needs are met; builds productive relationships with high-priority customers; takes accountability for customer satisfaction and loyalty; uses appropriate interpersonal techniques to prevent and resolve escalated customer complaints and regain customer confidence. 

• Influencing- uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes. 

• Monitoring Information-sets up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it. 

• Facilitating Change- encourages others to implement better approaches to address problems and opportunities; leads the implementation and acceptance of change within the workplace. 

• Innovation- create novel solutions with measurable value for existing and potential customers (internal or external); experiments with new ways to solve work problems and seizes opportunities that result in unique and differentiated solutions. 

Others: 

• Availability to travel domestically and internationally if required. 

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.