Job Description:
Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy Organization.
Responsibilities:
Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards
Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations
Ensures that TA- and program-level consistency is achieved by the design team
Accountable for the on-time design and delivery of new clinical systems, integration between systems, as well as any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
Interacts with and influences CDO and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, client Standard Operating Procedures (SOPs), and functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
Responsible for coaching and mentoring members of the team, as well as contributing to their skill development
Leads CDO and cross-functional innovation and process improvement initiatives
Qualifications
Bachelor s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
Must have 7+ years of hands-on technical Study build in EDC. Experience with technical study build in Medidata RAVE is required. Veeva EDC technical study build experience is a plus.
In-depth knowledge of clinical trial processes.
In-depth knowledge of CDASH (Required) and SDTM.
Demonstrated performance as a key contributor to initiatives and advancement of the organization.
Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor in a matrixed environment. Demonstrated effective communication skills and analytical skills.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.