Study Start -UP Manager

Veristat; Massachusetts; Remoto; USD 110.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Descrizione del lavoro

Veristat is seeking a Study Start-Up Manager to provide operational expertise and customer-focused leadership across multiple start-up teams involved in study activation. You will oversee start-up activities for studies across country, region, or globally, ensuring adherence to GCP, ICH, SOPs and regulations.

You will lead project teams, coordinate with internal departments and external partners, and drive on-time delivery of study milestones while maintaining high-quality regulatory submissions

Competenze

• Bachelor's degree in a relevant field required.
• 4 to 6 years in Clinical Operations or similar department required.
• SOCRA or ACRP certification and/or membership preferred.

Mansioni

• Provide operational leadership to start-up teams involved in site activation and start-up activities.
• Lead project teams to deliver start-up milestones on time and within regulatory requirements.
• Coordinate across departments and external stakeholders to ensure efficient study delivery.
• Maintain adherence to ICH/GCP, SOPs and applicable regulations.

Conoscenze

Communication skills

Leadership

Stakeholder management

Matrix environment

MS Office

Formazione

Bachelor's degree in a relevant field

SOCRA or ACRP certification

Strumenti

Microsoft Office

Descrizione del lavoro

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

Benefits vary by location and may include:

• 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.

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