Senior CDISC Consultant

Overview

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

As our Senior CDISC Consultant, you will be responsible for:

1. Educating and consulting internal and external Pinnacle 21 customers, including but not limited to: Product Leaders, Customer Success, Sales Enablement and Operations.
2. Leading multi-disciplinary functions within the Standards Consulting team by establishing and executing the strategic vision of Certara's data science software solutions.
3. Guiding Product teams and influencing prioritization of solution development based on user stories and your significant industry experience.
4. Continuously contributing to the industry as a thought leader, including presenting at events, developing educational materials, and providing guidance to industry leaders.

Responsibilities

Advocate and Communicator

1. Explains the product in detail proactively to internal (e.g., sales) audiences and clients via well-produced help articles/videos and other media; attends tradeshows to drive adoption and produces multiple publications or presentations per year (company webinars, industry journals, 3rd party conferences, etc.)-with external industry recognition as an expert in the field.
2. Collaborate with Customer Success team to ensure customers are aware and educated on the company's latest solutions and features.
3. Contribute to release prioritization based on deep domain knowledge.
4. Escalate issues to Support, Customer Success and/or Sales.

Strategy and Planning

1. Guide continued development of Metadata Management software solutions.
2. Help define and execute strategy of Standards Consulting team, including process, organizational capacities, resource management, and technology enablement.

Operational Management

1. Identify a process that provides advanced support for internal and external customers.
2. Develop and train SOPs related to Standards Management.
3. Develop and maintain a central repository of domain-specific knowledge for internal knowledge sharing, which enables external communication and education.

Qualifications

• Minimum 10 years' experience with clinical trial data regulatory submission requirements
• Education/experience relating to clinical trials data standards, including expert-level CDISC domain knowledge.
• Thought-leadership experience including developing and presenting novel content and participation in industry groups.
• Willing and able to travel approximately 10% of the time.

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.