Study Start Up Lead

Description

Purpose, Objectives and Scope of Position
As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start-up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local internal and external country teams, global study teams, and CROs is essential to this role.

Key Responsibilities

• Leading the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders.

• Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.

• Ensuring alignment with global strategies and timelines.

• Managing amendments throughout the study lifecycle.

• Identifying and driving opportunities for process automation, standardization, and innovation.

• Collaborating with regional and global counterparts to harmonize systems and improve timelines.

• Participating in external industry collaborations to influence country start-up environments.

• Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g., with Ethics Boards, Health Authorities).

Qualifications

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent.

• Postgraduate degree or master's degree highly desirable.

• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.

• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.

• Experience managing vendor/CRO relationships.

• Proven leadership or line management experience (for PLs).

Skills & Competencies

• Excellent communication and interpersonal skills.

• Strong organizational, analytical, and problem-solving capabilities.

• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.).

• Collaborative and adaptable mindset with attention to detail.

• Ability to lead through complexity and ambiguity, especially in matrixed and global teams.

• Fluency in written and spoken English is mandatory.

• Fluency in written and spoken language(s) of the host country is mandatory.