Study Start -UP Manager

Veristat; Massachusetts; Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Remote work options

Flexible time off

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Study Start-Up Manager to provide operational leadership for start-up and activation across multiple studies. You will drive the delivery of all start-up activities from a global to local scope, ensuring compliance with ICH/GCP and regulatory requirements.

Strong communication and cross-functional collaboration are essential in this fast-paced, matrixed environment. The role requires 4–6 years in Clinical Operations, a relevant Bachelor's degree, and preferably SOCRA/ACRP

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.

Responsibilities

• Provide operational expertise and customer-focused leadership to multiple operations teams involved in start-up and activation activities.
• Ensure effective and efficient delivery of all operational aspects of multiple studies through all phases of start-up.
• Oversee and manage start-up activities for a country, region, or global scope in accordance with Veristat policies and applicable regulations.
• Collaborate across departments and external partners to maintain timelines and quality standards.

Skills

Project leadership

Communication skills

Attention to detail

Microsoft Office

Cross-functional collaboration

Clinical Operations

Education

Bachelor's degree in life sciences

SOCRA or ACRP certification

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 teamsLearn more about our core values here!**What we offer**Benefits vary by location and may include:o Remote workingo Flexible time offo Paid holidayso Medical insuranceo Tuition reimbursemento 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.### Equal Opportunity EmployerVeristat 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