at Merck in Dover, Delaware, United States
Activities may include, but are not limited to:
+ Creates and develops clinical databases and data transfer files according to written specifications. Ensures adherence to clinical database standards, SOPs and Process Guidelines. Leads and participates in the review of eCRFs and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS)
+ Leads and participates in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical Data Management System (CDMS).
+ Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
+ Leads and participates in developing transformation logic, and scripts to aid in the flow of data downstream for Analysis and Reporting.
+ Interface with CDS manager/supervisor to assure consistency of technical and process strategies. Acts as a technical resource to other members of the group. Plans appropriately to ensure adherence to timelines. Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
+ Provide ongoing training and development to Clinical Database Developers on existing standards. Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.
+ Participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate CDS technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing clinical database support to other departments.
+ Assist clinical database manager/supervisor in project planning, manpower projections and resource allocations across therapy areas. Interface with clinical database manager/supervisor to assure consistency of technical and process strategies across all therapy areas.
Minimum education required:
+ Bachelor’s degree in computer science or equivalent professional experience to software design, procedure language, development theory and techniques, testing methodologies, and software documentation.
Required experience and skills:
+ Minimum 4 years of database development or data programming experience (Oracle PL/SQL).
+ At least 2 years of clinical databases development or programming experience.
+ Demonstrated strong technical proficiency in a Clinical Data Management Systems (i.e., Inform, Inform Architect, Central Designer, Medidata Rave).
+ Solid knowledge of MS Windows/Office software and exposure to web-based applications.
+ Ability to establish and maintain good working relationships with different functional areas.
+ Strong sense of urgency and customer focus.
+ Project Management skills * Ability to present in a group environment.
+ Leadership, verbal and written communication, interpersonal and organizational skills
+ Desire and ability to learn new processes and technologies.
+ Broad knowledge of Clinical Development and Regulatory Affairs requirements
+ Ability to multi-task, work independently, and good communication skills.
+ Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
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