**Requirements**:Bachelor's degree, preferably in IT, mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.Languages:- English business proficient**Skills**- Knowledge of database structures and available tools to manage, extract, report, and warehouse data.- Desirable knowledge of database structures and available tools to manage, extract, report, and warehouse data (SQL-PL/SQL scripting).- Desirable 4 years of database development or data programming experience, at least three of which including clinical databases.- Desirable technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer).- Desirable 4 years of experience with CDISC Standards (if possible), (SDTM, CDASH, Define.xml), XML, Java, ELT tools- 2+ years' experience in System Development Lifecycle Management / system validation knowledge.- Desirable experience with reporting tools such as SAS, Cognos or JReview.- Desirable experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.- Ability to collaborate and communicate with cross functional stakeholders to interpret and ensure quality report specifications and input to report development.- Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.- Strong organizational and critical thinking skills.- Keen sense of urgency and customer focus.- Ability to work cross functionally and as part of a team.- Able to work independently, under pressure and change environment with flexibility.- Activities may include, but are not limited to: _- Creates and develops clinical databases and data transfer files according to written specifications.- 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.- Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.- Creates and reviews reporting specifications to ensure high quality deliverables, meet SDTM structure requirements and the needs of the business.- Leads and participates in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database.- Participate in database Archiving and Decommissioning activities in support of multiple clinical programs (with Vendors interaction).- Coordinates and/or participates in the following activities: _- Develop required training and provide ongoing training and development to Developers on standards and Study Build, transformations, mapping, reporting and Archival Process.- Interfaces with functional manager to assure consistency of technical and process strategies across all therapy areas.- Plans appropriately to ensure adherence to timelines.- Acts as a technical resource to a functional group.- Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables.- Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines.- Trains new hires and participates in the interview process.- Leads and/or participates in activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives.- Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of a group.- Assist Manager/Associate Director in project planning, manpower projections and resource allocations across therapy areas.**Secondary** Language(s) Job Description**:**Search Firm Representatives Please Read Carefully****Employee Status**:Regular**Relocation**:**VISA Sponsorship**:**Travel Requirements**:**Flexible Work Arrangements**:Hybrid**Shift**:**Valid Driving License**:**Hazardous Material(s)**:**Requisition ID**:R289196
