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 will 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: Lead the country strategy for study start‐up driving efficiency, innovation and collaboration with external stakeholders.
Oversee Operations: Oversee start‐up operations to ensure timely and efficient site activation and regulatory compliance.
Drive Process Improvements: Identify and lead opportunities for process automation, standardisation and innovation at both the country and site levels.
Collaborate and Harmonise: Collaborate with regional and global counterparts to harmonise systems and improve timelines.
Manage Clinical Trial Submissions: Oversee the development and management of clinical trial submissions and amendments ensuring regulatory coordination.
Strategise on Budget & Contracts: 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: Participate in external industry collaborations to influence the country's start‐up environment.
Who You Are
You have a degree (MD, PhD, MA / MS, BA / BS) in life sciences or a related field. A postgraduate degree in clinical trials or clinical research is highly desirable.
You have demonstrated experience in clinical trial start‐up in Spain regulatory submissions and cross‐functional collaboration.
Proven track record in managing site relationships with a customer‐centric mindset and managing complex clinical trials start‐up (e.g., at least 2‐year previous experience as a Clinical Trial Monitor).
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 and in Spanish.
Ability to manage multiple priorities and work in a fast‐paced dynamic environment.
Ability to travel if needed.
Who we are
A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing 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.
Key Skills
Administrative Skills
Facilities Management
Biotechnology
Creative Production
Design and Estimation
Architecture
Employment Type: Full‐Time
Experience: years
Vacancy: 1
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