Clinical Data Management | Project Management | People Management | Technical Expertise PROFESSIONAL SUMMARY • Overall 21+ years of experience • 14+ years of experience in Team Management and Operation Management • Management expertise – Account Management, Client Relationship, Operations, People Management, Vendor Management, CDM Process CONTACT Resi.: Berlin, Germany Mobile: +49 15171310730 E mail: narendrasutar@rediffmail.com Setup • Functional expertise - Clinical Data Management and Programming, CDISC SDTM, GCP, FDA regulations, ICH guidelines, 21 CFR Part 11 and Life Science Domain • Technical expertise - Oracle Clinical 5.2, Medidata Rave, Inform 4.6, Central Designer, Sycamore Metadata Store (MDR), Oracle PL-SQL, DBeaver and VBA WORK EXPERIENCE PRINCIPAL CLINICAL DATA MANAGER PERSONAL DETAILS o Date of Birth: May-1978 o Marital Status: Married o Gender: Male o Citizenship: Indian, Germany Permanent Residence ship Bayer AG, Berlin, Germany Feb’20 – till date SERVICE DELIVERY MANAGER - CLINICAL DATA MANAGEMENT Cognizant Technology Solutions May’08 – Dec’19 LEAD CLINICAL DATABASE PROGRAMMER - CLINICAL DATA MANAGEMENT Tata Consultancy Services Nov’05 – Apr’08 SOFTWARE PROGRAMMER ICICI Bank Feb’05 – Nov’05 JUNIOR PROGRAMMER Konkan Railway Corporation Ltd. Jan’04 – Dec’04
Clinical Data Management | Project Management | People Management | Technical Expertise PROJECT/TEAM MANAGEMENT EXPERIENCE • In Bayer AG as Lead Study Data Manager and Project Data Manager (Feb 2020 – Till date) o o o CLINICAL SYSTEMS & PROCESSES o o o Phase I/II/III/IV Trials (Setup + Conduct + Closure) o InForm 4.6, Oracle Clinical 5.2, Rave, Sycamore Metadata Store (MDR) • In Cognizant Technology Solutions for end-to-end CDM Projects (May 2008 to Dec 2019) As Onsite Manager in Denmark at client Novo Nordisk o o o EDC, IV/WRS, IMPACT, Digital Document Manager, Laboratories, Systems Integration o SQL Scripts, Oracle PL/SQL o o o SOFT SKILLS o Excellent Interpersonal and Organisational Skills o Strong Analytical Aptitude o Business Logic o Patience o Perseverance Governs use of key data management elements across studies in assigned projects Ensures adequate application of Data Management Best Practices across studies within assigned projects Provides governance and oversight for outsourcing activities by providing input on budgetary items. Ensures smooth phase-transitioning of projects between research and development phases. Actively supports assessment of future trends o Serve as a bridge between Client and Upper Management at Cognizant Understand client requirement from resource and process point of view Improve the development of onsite delivery team with cross domain-training for increase in productivity and develop competency Implement process-oriented work streams for onsite team for better performance Maintain effective customer relations by ensuring consistent personnel practices within the project Establish and conduct Domain Knowledge bridge (Share Better Practices) between on onsite and offshore projects As Service Delivery Manager for end-to-end CDM Projects (Paper + EDC) (Clients: Sanofi, Novo Nordisk, AstraZeneca) o o Lead operations for Data Management Projects SME for Clinical Data Management o Monitor, Ensure and Support team for all end-to-end DM deliverables Resource competency enhancement, utilization, planning and optimization using various resourcing models Supervise risk management and mitigation plans at project level Monitor project delivery performance, customer metrics, LOB metrics and reports to senior management CDM Process improvement project planning, execution and o o o o other strategic goals for the functions o o Perform Project Costing, Billing and Work Orders Lead various FDA and Client Audits at project levels
Clinical Data Management | Project Management | People Management | Technical Expertise o o o o o Establish partnership with client delivery manager at functional and operational level Participate in Life Sciences RFPs, SOP writing and other SME inputs Leaded process automation projects Lead, design and execute project training plans for domain skills, soft-skills and other business functions Other all Operational and Project activities As Line Manager (DB Programming Team) for end-to-end CDM Project (Client: Novartis) o o o o o o o o o Act as SME and Line Manager of a team of Study-setup Lead a team, managing the daily activities and ensuring the quality of deliverables Provide review and guidance to the team for best clinical database programming Establish best clinical database programming practices in the team Plan and execute training sessions within the team for continuous improvement and learning Establish quality measurements for high quality programming and reduce postproduction changes Establish effective modes of communication between client management and company management Create and improve clinical domain understanding in programmers Perform resource utilization As Technical Lead for Migration Project (Client: Novo Nordisk) o o o Perform Clinical Database Setup and Programming based on specifications Perform project management activity such as project related report, Timelines designing, resource allocation Lead a team, managing the daily activities and ensuring the quality of deliverables. o • As Lead Clinical Data Programmer in Tata Consultancy Services Ltd. for end-to-end CDM Project (Nov 2005 to Apr 2008) (Client: Novo Nordisk) CLINICAL PROJECTS EXPERIENCE SUMMARY • As Lead Clinical Data Manager, (May’2008 to till date) (Bayer AG, Novo Nordisk, AstraZeneca, Sanofi) Tools & CDMS: InForm 4.6, Oracle Clinical 5.2, Medidata Rave, Central Designer, Sycamore Metadata Store (MDR) Process: EDC/Paper, IV/WRS, IMPACT, Digital Document Manager, Laboratories, Systems Integration
Clinical Data Management | Project Management | People Management | Technical Expertise • As Lead Clinical Data Programmer (Nov’2005 to Apr’2008) (Novartis, Novo Nordisk) Tools & CDMS: Oracle Clinical 4.5, TOAD, SQL Scripts, Oracle PL/SQL Process: EDC, Laboratories, Systems Integration PROJECT/PROCESS IMPROVEMENT PROJECTS • Risk Based Quality Monitoring Implementation Project (Cognizant Technology Solutions/AstraZeneca) • Costing and Billing re-defining (Cognizant Technology Solutions) • Trial Complexity and Costing Project (Cognizant Technology Solutions) • CDM Process and Report Automation (Cognizant Technology Solutions/Novo Nordisk) • Clinical Data Mining (Cognizant Technology Solutions) • Data Validation Re-defining (Cognizant Technology Solutions/Novo Nordisk) • Sycamore Metadata Store (MDR) enhancement/maintenance project (QC) (Bayer AG) • TransCelerate Optimized Data Collection (Bayer AG) ACADEMIC PROFILE Bachelor of Sciences (Physics) University of Mumbai, May 2000 Diploma in Software Eng. National Institute of Information and Technology (NIIT), Jun 2003
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