Study Start-Up Manager

Summary

The Study Start-Up Manager provides operational expertise and customer focused leadership to multiple operations teams involved in start-up and activation activities. Ensuring the effective and efficient delivery of all operational aspects of multiple studies through all phases of start-up. This oversight and management may be for a country, region or global. The Study Start-Up Manager does so in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) and all applicable country and local regulations.

Job description

Requirements

• Bachelor's degree in a relevant field required; biological science, Pharmacy, Nursing, or related field preferred.
• 4 to 6 years in Clinical Operations or similar department required, with experience leading project teams to success.
• SOCRA or ACRP certification and/or membership preferred.
• Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment.
• Excellent communication skills and attention to detail within a fast-paced office environment required.
• Willing and able to work well in a matrixed environment, across departments, across levels, amongst competing priorities and multiple stakeholders (both internally and externally).
• Expert skills in Microsoft applications.
• Proven clinical development experience in the operational aspects of clinical studies, including the ability to lead, motivate, mentor, coach and train assigned team members.
• Excellent oral and written communication skills in English (other languages a plus), to effectively support and manage exchanges with external customers.

Benefits

• Remote Working
• Flexible Time Off
• Paid Holidays
• Medical Insurance
• Tuition Reimbursement
• Retirement Plans

Company overview

Veristat is a science-first full-service clinical research organization (CRO) and consultancy that specializes in advancing complex and novel therapies through integrated strategic planning, regulatory expertise, and clinical trial execution. With nearly 30 years of experience, the company focuses on supporting emerging, small, and mid-size biopharmaceutical companies in developing innovative treatments for challenging therapeutic areas including oncology, neurology, rare diseases, infectious diseases, and metabolic disorders. Veristat's comprehensive services span the entire drug development lifecycle, from early-phase clinical trial design and execution to regulatory submissions and post-marketing support. The company has established a strong track record in biologics, gene therapies, and cell therapies, having supported the first gene therapy approved in Europe. Operating globally with offices across North America, Europe, and Asia, Veristat employs a team of scientific experts who combine bold thinking with practical execution to help clients navigate regulatory complexities and accelerate the delivery of life-changing therapies to patients in need.