AD Clin Data Sys & Standards

Date Posted: 1/10/2025

Associate Director Clinical Data Systems & Standards
Morris County, NJ (Hybrid 2-3 days onsite)
Biotech Pharmaceutical Client

Summary:
In this role, you will support and develop for clinical data and standardization, increase efficiency of clinical database builds, data visualization, and enable compliance to CDISC standards -CDASH, SDTM- while implementing industry best practices.

Responsibilities:
Will be the expert with clinical systems and platforms that include, Medidata, Veeva CDMS/CTMS, CliqSense and JReview configurations, capabilities, and system behaviors. Lead and deliver new capabilities, innovative technical solutions and clinical system integrations that enable future proof study execution. Provide technical leadership focused on technology enablement for EDC, Data Visualization, and other data collection display systems. Technical support for system integration, patient facing technologies and data reporting tools. Ensure continuous improvement of processes, tools and outputs to be used to facilitate advancement of study portfolio. Liaise with systems vendors to develop and maintain system environments to support the organization. Lead efforts to identify future system capability and enhancement opportunities. Technical study lead to work with study team counterparts on study deliverables from external partners ( Functional Service Providers, CROs, technology providers) performing data collection and data visualization services on behalf of the company. Oversee the build, maintenance, and deployment of study databases to collect clinical trial data, including configuring custom integrations if applicable. Manage work assignments to ensure timely delivery of study databases, data review reporting, external data management, and other study related technical components. Collaborate with Data Management to develop appropriate timelines for development and deployment of study databases, visualizations and the management of external data and reporting. Identify and resolve technical system issues which may negatively impact delivery of study databases and data visualizations. Responsible for ensuring the activities required to build out standard objects ( eCRF forms, edit checks, eCRF entry guidelines, standard data review reports) that are compliant with CDISC (SDTM) are implemented. Collaborate with cross functional core roles (Data Managers, Medical Monitors, Statisticians, Programmers) to implement new or modified global library objects. Develop and monitor key standard clinical systems performance metrics. Adhere to procedural documents and participate in reviewing, authoring and/or updating documents reflective of industry standards. Develop strong and productive working relationships with key stakeholders with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management. Represent the company in interactions with key external partners as part of any committee or industry group relating to clinical systems. Participate in the development and implementation of new processes and procedures, updates SOPs as appropriate. As needed, accountable for the management and development of direct reports including performance management and career development. Supports financial management of CDO vendors, i.e. budget and invoice review, forecasting of future work, etc. Encourage cross-functional team collaboration for consistency across projects

Supervisory Responsibilities:
Potential supervision of Clinical Systems staff. The incumbent works closely with internal and external partners to provide database operations and standards expertise. The incumbent participates in interactions and presentations.

Required:
BS or BA degree in a relevant scientific field required. 7-8 years’ experience in clinical systems execution and support, including EDC, data visualization, and data standardization highly preferred. Minimum 5 years of experience within the Pharmaceutical or Biotech industry. Experience leading technical cross-functional system and process initiatives required. Expertise in the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena. Strong knowledge of Veeva and other industry leading data capture and reporting tools (e.g. Medidata Rave, CDMS, JReview, ClikSense, Spotfire, IRT, ePRO etc.) and well versed in industry trends and emerging technologies supporting data collection. Expert in clinical data standards related to capture, quality control and reporting of data ( CDISC). Strong communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers. Ability to interpret end user requirements and develop appropriate data capture and visualization solutions. Knowledge of FDA/ICH/GCP guidelines and industry standard practices regarding data capture, clinical data structure, relational database, data processing, analysis programming, and data exchange with alternate formats. Detailed knowledge of multiple data management systems, reporting tools, basic familiarity with SAS datasets and conversion procedures.

Excellent base salary plus bonus (depending on experience).

Please contact Darren Gutowski at dgutowski@clarkdavis.com