Principal Clinical Data Manager

Veristat, LLC; Massachusetts; Hybrid; USD 114,000 - 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, LLC is seeking a Principal Clinical Data Manager to independently manage data activities from study start-up through database lock for complex clinical research projects. You will lead a team of CDMs, ensuring data quality and SOP compliance while collaborating with management on process improvements.

The role requires 7+ years in clinical data management, 5+ years of leading project teams, and strong GCP knowledge. Remote-friendly, with competitive salary and benefit offerings.

Qualifications

• Bachelor’s degree in a related field; 7+ years’ clinical data management experience in a clinical research setting.
• 5+ years of leading project teams.
• Thorough knowledge of ICH GCP guidelines and regulatory requirements.
• Experience with clinical trial databases and applications.

Responsibilities

• Perform data management tasks from study start-up through database lock for assigned projects.
• Lead a team of CDMs to ensure SOPs and sponsor requirements are met.
• Provide training to data managers and other functions as needed.
• Promote efficient use of resources and knowledge sharing across the organization.

Skills

Team leadership

Project management

Communication skills

Regulatory knowledge

Strategic thinking

Education

Bachelor's degree in a related field

Tools

IBM Clinical Development

Medidata RaveX

Job description

Principal Clinical Data Manager Working independently and in consort with management, the Principal Clinical Data Manager is responsible for the performance of data management tasks from study start-up through database lock for assigned clinical research projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data quality and documentation on clinical research projects. The Principal Clinical Data Manager will work on mid-to-large complex projects in various indications, at times serving as program manager, overseeing multiple studies under the same client. S/he will lead a team of CDMs to ensure all the contracted activities are carried out according to the Standard Operating Procedures of Veristat and/or Sponsor specific requirements. In consort with Data Management leadership, the Principal Clinical Data Manager promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices. S/he, in consultation with the managers, will assist with the training of other data managers on project specific and general data management processes, procedures and systems, as well as providing training to other functions across the company as needed.

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:

The estimated hiring range for this role is $114K – 150K plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.

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 related field & 7+ years of relevant experience; at least 5 years’ experience in clinical data management experience in a clinical research setting and 4 years of experience in leading project teams, required. Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research. Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies. Demonstrated ability to lead by example, and demonstrated skill for technical leadership of staff. Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes . Demonstrated ability to operate with the “big picture” in mind and serve as a thought partner to management as needed. Expert level skills in use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX), with a strong desire and ability to learn new applications. Detailed understanding of project planning and management methods. Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment. Ability to work in different projects with different priorities and act as team mentor, and provide data management expertise.

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.

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.

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