**Brief Description of Position** Responsibilities but not limited to: - Collect, assign, track, and prioritize requests from users requiring modifications (upgrades or bug fixes) to existing systems; - Develop business case in collaboration with process owners/stakeholders and our Research & Development Division IT for new solutions. - Approve change requests for upgrades/bug fixes/data changes and coordinate release planning and assessment for the business in collaboration with IT. - Ensure business needs and criticality of functionality are correctly documented in System Development Life Cycle (SDLC) documentation. - Review and approve appropriate validation documentation. - Represent business users and a voice of reason for Business users during discussions with the system vendors & IT Product Manager to ensure right enhancements are proposed & identified Partner with the IT Product Manager & Business Analyst to enable new system enhancements. - Work with solution provider to ensure appropriate enhancements are incorporated in vendor roadmap that not only supports current process/needs but also future vision and innovative technology options. - Periodically assess and update if needed Communicate system functionality changes and impact to existing processes to the users in a concise and timely manner. - Communicate and coordinate the implementation of system changes to Business Process/Sub-process Owners, requestors, and stakeholders - Monitor support metrics and performance of the system on routine basis to assess needs for improvements (added resources or technology improvements). - Work with business to ensure optimized use of product features. - Facilitate trainings to ensure users are appropriately trained in the use of the system - Partner with the IT Support Lead to coordinate downtime communications - content, timing, contacts, etc. - Work with IT and support team to create user provisioning and deprovisioning process - Periodically audit user access to system to ensure only intended users have access. - Manage UAT related activities such as assessing UAT needs, developing and communicating high-level UAT plans - Coordinate UAT by identifying testers for UAT, ensuring proper training is completed, develop test cases, track issues during testing and ensure proper documentation is completed prior to deployment. - Responsible for completion of risk and privacy assessments and ensure adherence to risk and privacy policies. - Act as primary business contact for assigned systems during audits and inspections and collaborate with IT and process owners to respond to all audit and inspection related requests in a timely manner. - Supporting Specimen Lifecycle Management department. **Position Qualifications**: **Education Minimum Requirement**: - BS degree > +12 years experience; or - MS/MBA/JD degree >+10 years experience; or - PhD +5 years experience. **Required Experience and Skills**: - Five to ten years of experience in clinical research/clinical development - At least five years of experience in technology implementation, business process improvement, project management, systems analysis or systems maintenance/support - Basic understanding of System testing & providing training to user communities - Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required. - Basic knowledge of Site Monitoring, Study Start up, Data Management, Pharmacovigilance, Essential Document Management, and Investigator/ Study Coordinator roles/ responsibilities. - Critically evaluate process implications of system changes and deal with conflict and bring to resolution. - Able to identify critical input and outputs that drive business processes and dependencies on process (workflow) vs. technology (dataflow). - Experience with critical clinical systems such as CTMS, eTMF, Electronic Data Capture (EDC) system, clinical portal and basic reporting and MS Office tools. - Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. - Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs - Skilled in MS Access, MS Excel, SQL or other database/query tools a plus. - Recognized as “team player” - Possess good project management skills - Committed to continuous improvement - Analytical ability, good judgment, ability to multi-task - Strong verbal & written communication skills - Ability to proficiently interact with all levels of management and exert influence to achieve results. - Specimen lifecycle management experience preferred. EligibleforERP MRLGCTO ONEGDMS We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by