Clinical Operations Study Startup Specialist

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.

• 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.

• 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.

• You have excellent communication, interpersonal, and problem-solving skills, with a collaborative mindset.

• You are fluent in both written and spoken English, and in the language(s) of the host country.

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