Principal Clinical Data Manager

Veristat; United States; On-site; CAD 158,000 - 208,000; 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 Principal Clinical Data Manager to lead data management activities from start-up through database lock on mid-to-large clinical trials, including paper-based and EDC studies. You will work independently and with management to ensure high data quality and robust documentation.

You will manage a CDM team, align with SOPs, train other data managers, and share best practices across programs, contributing to efficient operations and client satisfaction.

Qualifications

• Bachelor’s degree in a related field; 7+ years in clinical data management.
• At least 5 years’ clinical data management in clinical research.
• 4 years of leading project teams.
• Strong knowledge of ICH GCP and regulatory guidelines.

Responsibilities

• Lead a team of CDMs to ensure contracted activities meet SOPs.
• Promote consistent operations and efficient use of resources.
• Assist with training of other data managers and cross-functional training.

Skills

Clinical data management

Team leadership

Quality documentation

Data management systems

Regulatory knowledge

ICH GCP familiarity

Leadership ability

Education

Bachelor’s degree in related field

Tools

IBM Clinical Development

Medidata RaveX

Clinical trial databases

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.

Job Description

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!

• 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.

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