Study Start -UP Manager

Veristat, LLC; Massachusetts; Remote; USD 90,000 - 150,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Study Start-Up Manager to lead cross-functional start-up and activation teams across studies, regions, or globally. You will drive operational excellence in line with SOPs, GCP, ICH, and regulatory requirements.

The role requires 4–6 years in clinical operations and strong leadership abilities to manage multiple stakeholders, with a willingness to work in a fast-paced, matrixed environment. Remote work options are available.

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.
• 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).

Responsibilities

• Provide operational expertise and leadership to start-up and activation teams.
• Oversee multiple studies through all start-up phases.
• Ensure delivery of start-up activities in accordance with SOPs, GCP, ICH and regulations.

Skills

Excellent communication

Leadership and mentoring

English proficiency

Matrixed environment

Attention to detail

Operational start-up experience

Clinical development experience

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 Veristat
480+ oncology projects in the past 5 years
350+ rare disease projects delivered in the past 5 years

Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
Learn more about our core values here!

What we offer

• Remote working
• Flexible time off
• 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.

Equal Opportunity Employer

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives. We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen. We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace.

Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices.

Reasonable Accommodations

Veristat is dedicated to providing an accessible and inclusive application experience for all candidates. If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our Talent Acquisition team at [e-mail] or [phone]. We will work with you to meet your needs, ensuring a fair process. All requests in relation to your application will be treated confidentially. For more information about how we collect and store your personal data during the hiring process, please see our Career Recruitment Notice