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.
#LI-SI1
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Skills Required
- Bachelor's degree in a related field
- 7+ years of relevant experience
- At least 5 years of clinical data management experience in a clinical research setting
- 4 years of experience leading project teams
- Thorough knowledge of ICH Good Clinical Practice guidelines and applicable regulatory rules and guidelines
- Knowledge of medical terminology, clinical trials, and clinical research
- Working knowledge of CRO relationships and regulatory obligations with pharmaceutical and biotechnology companies
- Ability to provide technical leadership and lead by example
- Ability to serve as an internal and external consultant and influence without authority
- Ability to guide project teams toward mutually acceptable outcomes
- Ability to advise management as a strategic thought partner
- Expert-level computer technology skills, including clinical trial databases and applications such as IBM Clinical Development and Medidata RaveX
- Detailed understanding of project planning and management methods
- Excellent interpersonal, communication, and organizational skills
- Ability to work independently and in a team environment
- Ability to manage competing priorities across different projects
- Ability to mentor teams and provide clinical data management expertise
What We Do
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases. We are…Bold. Scientific. Versatile. Veristat. - Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant
