Clinical Study Start Up 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.

A healthier future. It is what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That is what makes us Roche.

At Roche 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.

We have an opportunity for a Study Start Up Lead to join Roche for a 13 months maternity leave cover in a full time fixed term contract capacity. As a key member of our Country Study Start-Up team, you will drive and facilitate the efficient initiation of clinical trials, ultimately helping to deliver innovative treatments to patients. You'll work in a highly collaborative and cross-functional environment, where you can influence and shape our clinical trial delivery strategy. This is a unique opportunity to use your expertise to make a meaningful impact by ensuring seamless trial execution for patients, investigators, and clinical site staff.

The opportunity

• Lead Country Strategy: You will lead the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.

• Oversee Operations: You will oversee start-up operations to ensure timely and efficient site activation and regulatory compliance.

• Drive Process Improvements: You will identify and lead opportunities for process automation, standardization, and innovation at both the country and site levels.

• Collaborate and Harmonize: You will collaborate with regional and global counterparts to harmonize systems and improve timelines.

• Manage Clinical Trial Submissions: You will oversee the development and management of clinical trial submissions and amendments, ensuring regulatory coordination.

• Strategize on Budget & Contracts: You will provide strategic oversight for all aspects of budgeting and contract management, including developing budget strategies and negotiating with internal and external stakeholders.

• Influence the Environment: You will participate in external industry collaborations to influence the country's start-up environment.

Who You Are

• You have a degree in life sciences or a related field- a postgraduate degree is highly desirable.

• You have demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration. Experience in the Cardiovascular and/or Metabolism disease areas is desirable.

• You possess a strong understanding of ICH-GCP, EU CTR, and local regulatory environments.

• You have excellent communication, interpersonal, and problem-solving skills, with a collaborative mindset.

• You are fluent in both written and spoken English.

This role is only open to candidates that have full eligibility to live and work in Australia.

We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team.

Roche offers rewarding growth opportunities and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. 

Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients. Our work gives people more time to be with the ones they love. Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for Infectious Disease, Cardiovascular Metabolic, Oncology, Neurology, Immunology and Ophthalmology.

We care about you - as a whole person. That's why we place your individual health, and professional growth at the very heart of what we do. Your well-being is one of our top priority, because when you're thriving, we all succeed. We offer access to mental health awareness and wellness initiatives that cater to your unique needs - because we understand that well-being is personal.
 

We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances or workplace adjustment that may require consideration.

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.