Senior Clinical Operations Lead at Roche

The Position

Roche Pharma in Johannesburg has an exciting opportunity for a Senior Clinical Operations Lead who will be responsible for providing leadership and regional / local strategic planning and  operational delivery of assigned clinical studies through all the phases of study management (Preparation, study start-up, conduct, close-out). This will be done in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments.

To be a part of a combination of sub-communities that comprise the larger Clinical Operations Community at Roche, participate in or lead Work Product Teams and enable clinical trial delivery in a broad flow approach with a focus on delivering value for patients,  investigators and the clinical site!

Key Challenges:

• Lead and contribute to clinical trials or enabling project teams.
• Drive continuous improvement and change management activities.
• Strategically lead collaboration across the team and other functions.
• Ensure adherence to ICH, & SA GCP and regulatory guidelines.
• Maintain a strong working knowledge of Clinical Operations and drug development.
• Understand the impact of team decisions on other parts of the business.
• Identify vendors, build relationships and ensure their performance.
• Anticipate the external environment for operationalizing clinical trials.
• Influence and shape the clinical trial landscape for long-term success.
• Provide subject matter expertise across operationally strategic activities.
• Contribute to sub-communities within the larger Clinical Operations Community.
• Drive patient-centricity throughout clinical operations and drive the evolution of global clinical operations.
• Inspire and empower talent across Clinical Operations and the Roche family in the spirit of one Roche.
• Proactively manage and align with stakeholders to achieve the Pharma Vision.
• Promote and supports quality and compliance.

Who you are as our ideal candidate:

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

This challenging role requires the following qualification, experience and skills:

• University degree or equivalent; preferably in medical/science –related field.
• A minimum of 8 years’ experience in clinical research/development or related industry experience with a strong working knowledge of Clinical Operations and drug development or related expertise with experience in leading cross-functional study teams in clinical research.
• Whilst this is an individual contributor role, previous experience in people/line management is a plus. A career path as CRA, Project Lead/Manager, Start-up professional will be a key added advantage.
• Required knowledge: Good understanding of ICH GCP and SA GCP, as well as quality standards related to study management, operational knowledge of clinical development, including vendor/CRO resource management and risk management.
• Required skills: Proficient problem-solving skills through thorough analysis of information,Competency in project management, including risk management and budget planning, Demonstrated ability to prioritize and manage multiple tasks, with strong self-motivation and achievement orientation, Proficiency in budget negotiation and tracking for study conduct.
•  Required to be a team player with strong collaboration skills.