Study Start Up Lead
Roche · Kyiv
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The Position
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. You'll 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 country's 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 years of 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.
Who we are
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.