Senior Manager Customer Success

Job Description Job Requirements & Responsibilities: Experience working with Pharma / Clinical Development / eClinical software products and services is required. Experience in Clinical Data Repository/Warehouse (CDR/CDW) and Metadata Repository is an advantage. Must have knowledge and experience with emerging regulations for the Life Sciences industry (e.g., 21 CFR 11, 21 CFR 211, 21 CFR 820, EU Annex 11). Must have experience in qualification, testing, and validation approaches aligned with industry best practices for CSV (e.g., GAMP V, PIC/S, PDA TR18, and FDA Guidelines (2002 CDRH)). Conduct software system validation activities for core software applications and customized solutions within agreed timelines. Involve and contribute in Validation Planning, Requirements analysis, and sessions by liaising with business and IT team located onsite or offshore. Prepare, review, and support key SDLC and Validation deliverables such as URS, FRS, Design/Configuration specifications, Validation Plan, Validation Summary Report and provide constructive feedback. Create, review, and approve Test/Validation cycles, Test Scenarios (TOL), Requirement Traceability Matrix (RTM), IQ’s (Installation Qualification), OQ’s (Operational Qualification), UAT/PQ’s (Performance Qualification/User Acceptance Testing), and ongoing validation efforts. Provide support in preparing 21 CFR Part 11 Assessment Checklist, Validation Plan, Validation Summary Report. Peer review of Test Cases/Scripts, dry run and execution of Test Cases/Scripts. Able to train and support junior team members located onsite and offshore. Qualifications and Education Requirements: Skills: Excellent communication skills Strong project management & analytical skills with a clear focus on end results Demonstrable project management skills with a record of achievement to tight timescales Good relationship management skills (listening, understanding, communication) Highly organized and self‑motivated with the ability to prioritize tasks Must be able to work accurately, under pressure, to meet strict deadlines Company Description Maxis Clinical Sciences provides complete solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and is an integrated research competence center. The company provides 24 x 7 delivery globally, with teams across the world’s three largest continents – North America, Europe and Asia. We operate with a problem‑solving approach that believes in promoting genuine relationships & steady communication. It works as a true clinical and digital competence center and provides services with 200 plus techno‑functional, domain experts, each with 12+ years of average experience. Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient‑centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc. #J-18808-Ljbffr 6AM City, LLC