The PositionAt 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. Every role here connects to something real: the health and lives of patients.
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.
The Opportunity:
You will lead the country strategy in a disease area for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.
You will oversee start-up operations to ensure timely and efficient site activation and regulatory compliance.
You will identify and lead opportunities for process automation, standardization, and innovation at both the country and site levels.
You will collaborate with regional and global counterparts to harmonize systems and improve timelines.
You will oversee the development and management of clinical trial submissions and amendments, ensuring regulatory coordination.
You will provide strategic oversight for all aspects of budgeting and contract management, including developing budget strategies and negotiating with internal and external stakeholders.
You will 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 with 1-3 years of experience in submissions, and cross-functional collaboration.
You have demonstrated experience in clinical trial start-up
Proven track record in managing site relationships with a customer centric mindset andmanaging complex clinical trials start-up
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.
Fluency in written and spoken English is mandatory
Ability to manage multiple priorities and work in a fast-paced, dynamic environment.
Ability to travel if needed.
Preferred:
Relocation Benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
We use artificial intelligence to screen, assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
