Study Start Up Lead at F. Hoffmann-La Roche Ltd - Poland

Kyiv, , Ukraine -

Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

0.0

Posted On

14 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Study Start-Up, Clinical Trial Initiation, Regulatory Compliance, Process Automation, Standardization, Clinical Trial Submissions, Budget Management, Contract Management, ICH-GCP, EU CTR, Ukrainian Legislation, Communication, Problem-Solving, Collaboration, Leadership

Industry

Biotechnology Research

Description

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 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. 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 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. 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 experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration. You possess a strong understanding of ICH-GCP, EU CTR, and local regulatory environments. A deep, practical understanding of the Ukrainian legislation and operations are mandatory. You have excellent communication, interpersonal, and problem-solving skills, with a collaborative mindset. You are fluent in both written and spoken English, and Native fluent in Ukrainian 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.

Responsibilities

The Study Start Up Lead will drive and facilitate the efficient initiation of clinical trials by leading country strategy, overseeing start-up operations, and driving process improvements for efficiency and innovation. This role involves managing clinical trial submissions, providing strategic oversight for budgeting and contracts, and collaborating globally to harmonize systems and timelines.