Clinical Study 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.

The role focuses on the responsibilities to ensure leadership and execution of one or more sponsored interventional trials or managed primary data collection non-interventional studies the effective and efficient delivery of all operational aspects in accordance with the appropriate quality standards including ICH/GCP and GVPs/GPPs.

Your Responsibilities

• Ensures study adherence to appropriate guidelines (ICH GCP/GVP/GPP) relevant regulations and Roche procedural documents. Ensures study inspection readiness at all times. Ensures the completion and finalization of any corrective and preventive action plans resulting from site audits and inspections

• Provides operational input and insights into the development of study protocols Clinical Study Reports informed consent form and protocol feasibility questionnaires

• Promotes operational excellence. Oversees the delivery and maintenance of essential study plans and systems (e.g. site & country selection and monitoring plan; study tracking systems clinical supply; vendor oversight plan; RBQM or equivalent risk management activities). Ensures accurate tracking and reporting of study metrics

• Chairs Study Management Team meetings and organizes the investigator meetings and study kick-off meetings

• Establishes and maintains study budgets and approves invoices identifies and communicates any issues/variances with study budgets and action plans for resolution

• Accountable for all vendor related operational study deliverables according to timelines budget operational procedures quality/compliance and performance standards. Leads vendor selections by reviewing proposals and providing recommendations reviews and negotiates clinical work orders. Maintains oversight of vendor performance issues and their resolution and identifies systematic issues and coordinates any corrective action. Ensures vendors receive appropriate training.

• Ensures proper handling of all study close out activities including but not limited to the site close out final drug accountability final safety reconciliation and Inspection readiness of Trial Master File documentation.

Who you are

• Strong leadership skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies.

• Proven strategic capabilities organizational awareness and proactive planning with embedded contingencies and risk management mindset.

• Clear understanding and experience applying ICH/GCP and/or GVP/GPPs and applicable regulations including awareness of quality requirements.

• Well-developed written and verbal communication skills demonstrated by an ability to present clear instructions/directions to motivate your team negotiate with peers and partners and influence cross functionally.

• Excellent problem solving negotiation and conflict resolution skills

• Borderless Collaboration: working closely with other countries/communities/teams embracing the loop of sharing and learning together to co-create Solutions

• Budget Management- cost effective management with limited unforeseen cost overruns.

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.