Study Start -UP Manager

Veristat • Massachusetts, MA

7d

About The Position

The Study Start-Up Manager provides operational expertise and customer-focused leadership to multiple operations teams involved in study start-up and activation activities. The role oversees and manages effective, efficient delivery of operational aspects of multiple studies through all start-up phases, with scope that may cover a country, region, or global operations. Work is performed in accordance with applicable Veristat policies, Standard Operating Procedures (SOPs), conventions, instructions, current Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidance, and applicable country and local regulations.

Requirements

• Bachelor’s degree in a relevant field is required.
• 4 to 6 years of experience in Clinical Operations or a similar department, including experience leading project teams to success.
• Thorough knowledge of clinical operations, the clinical development process, ICH/GCP, and the regulatory environment.
• Excellent communication skills and attention to detail in a fast-paced office environment.
• Ability to work effectively in a matrixed environment across departments and levels, managing competing priorities and multiple internal and external stakeholders.
• Expert skills in Microsoft applications.
• Proven clinical development experience in operational aspects of clinical studies.
• Excellent oral and written communication skills in English.

Nice To Haves

• A degree in biological science, Pharmacy, Nursing, or a related field is preferred.
• SOCRA or ACRP certification and/or membership is preferred.
• Knowledge of other languages is a plus.

Responsibilities

• Provide operational expertise and customer-focused leadership to operations teams involved in start-up and activation activities.
• Oversee and manage the effective and efficient delivery of operational aspects of multiple studies throughout all start-up phases.
• Lead, motivate, mentor, coach, and train assigned team members.
• Support and manage exchanges with external customers.

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

What This Job Offers

• Job Type: Full-time
• Career Level: Manager