Clinical Trials Administrator

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At Roche/Genentech 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.

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. Youll work in a highly collaborative and cross-functional environment where you have the opportunity to 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.

Vendor Management

The Role

• 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 lead 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 local regional and global counterparts to harmonize systems and improve timelines.
• Manage Clinical Trial Submissions: You will lead the development and management of clinical trial submissions and amendments ensuring regulatory coordination.
• Strategize on Budget & Contracts: You will provide strategic oversight for and operational delivery of 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 countrys start-up environment.
• Payments and Vendors Management: Strategically oversee and manage site payment processes budget escalations financial reporting and the reconciliation of financial activities. Contribute to local vendor management (excluding CROs) as required to support site activities.
• Manage Post-trial access Submissions and execution: You will lead the development and management of post-trial access submissions and amendments ensuring their strategic planning and execution in accordance with regulatory requirements and local procedures.
• Lead a Team (if applicable): If you are a People Leader you will provide coaching support and leadership to a team championing inclusive behaviors and helping them grow their skills and careers.

Who You Are

• You have a degree (MD PhD MA/MS BA/BS) in life sciences or a related field. A postgraduate degree is highly desirable.
• You have demonstrated strong experience in clinical trial start-up regulatory submissions and cross-functional collaboration (at least 4 yearsof relevant clinical trial operations experience).
• You possess a strong understanding of ICH-GCP EU CTR and local regulatory environments. Proficient and practical understanding of Ukrainian clinical trial legislation operations and regulatory environments (including medicinal products and medical devices) is mandatory.
• You have excellent communication interpersonal and problem-solving skills with a collaborative mindset.
• You are able to work independently and responsibly with respect to shared values and goals.
• You are fluent in both written and spoken English and Native in Ukrainian.
• You are a resident of Ukraine able to work in the Roche Ukraine office in Kyiv and willing to travel.

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.