Study Start-up Lead

Description:

Veristat is seeking a Study Start-Up Lead (SSUL) to provide operational expertise and customer-focused leadership to multiple operations teams responsible for start-up and activation activities across various clinical studies. This role involves overseeing the efficient and effective delivery of all operational aspects throughout all phases of study start-up, whether at a country, regional, or global level. The SSUL will ensure compliance with Veristat Policies, Standard Operating Procedures (SOPs), conventions, and applicable regulations, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) standards.

Key Responsibilities

• Lead and manage multiple operations teams to ensure successful study start-up and activation.

• Oversee operational aspects of clinical studies, ensuring timelines, quality standards, and compliance are met.

• Coordinate activities across various functions and stakeholders, internally and externally.

• Provide leadership, mentorship, coaching, and training to assigned team members.

• Ensure adherence to Veristat policies, SOPs, and regulatory requirements.

• Collaborate with cross-functional teams to manage competing priorities and multiple stakeholders.

• Support communication with external customers and internal departments in a matrixed environment.

• Monitor project progress, report on key metrics, and drive process improvements.

Requirements

• Bachelor’s degree in a relevant field (Biological Science, Pharmacy, Nursing, or related).

• 4–6 years of experience in Clinical Operations or a similar department with proven leadership skills.

• SOCRA or ACRP certification/membership preferred.

• In-depth understanding of clinical development processes, ICH/GCP, and regulatory environments.

• Strong communication skills, attention to detail, and ability to manage multiple priorities.

• Proficiency in Microsoft applications and experience in operational aspects of clinical studies.

• Ability to travel up to 15% (US, Canada, or International).

What We Offer

• Remote working flexibility.

• Flexible time off and paid holidays.

• Medical insurance and retirement plans.

• Tuition reimbursement.

• Inclusive and diverse workplace culture with a global presence.