Study Start -UP Manager

Veristat; Boston (MA); Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Remote working

Flexible time

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Study Start-Up Manager to provide operational leadership across start-up and activation activities for multiple studies. You will oversee delivery of start-up tasks in compliance with GCP, ICH, SOPs, and regulatory requirements, coordinating with cross-functional teams globally.

You will lead project teams, mentor staff, and ensure timely execution in a fast-paced environment, leveraging your extensive clinical operations experience and strong communication skills.

Qualifications

• 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.

Responsibilities

• Provide operational leadership across start-up and activation activities for multiple studies.
• Ensure delivery of start-up tasks in compliance with GCP/ICH, SOPs and regulatory requirements.
• Coordinate with cross-functional teams globally to meet timelines and quality standards.
• Lead, mentor and develop study start-up staff and project teams.

Skills

Leadership

Communication skills

Attention to detail

Mentoring/ coaching

Microsoft Office

Education

Bachelor’s degree in a relevant field

Tools

Microsoft Office

Job description

Job Description:

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.

Make an Impact at Veristat!Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.105+ approved therapies for marketing applications prepared by Veristat480+ oncology projects in the past 5 years350+ rare disease projects delivered in the past 5 yearsFlexible, inclusive culture — 70% remote workforce, 66% women-led teamsLearn more about our core values

What we offer

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

What we look for

• 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.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.