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Sr Manager OR DGM - Clinical SAS

Bengaluru, KA
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  • Miscellaneous
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Job Details

Job Descriptionposition summaryThis role involves Leading and Managing delivery of project/s in terms of resourcing, quality, timeliness, efficiency and high technical standards for outputs produced by the Statistical Programming group.Be responsible for overall sucecss and leading initiatives for quality and producitivty enhanacement. Support and assist operations manager in management and tracking of projects.Key Result Areas Technical Responsibilities Leading and contributing to technical strategy for a portfolio of studies (project/TA).Programming in SAS for analyzing data and producing Efficacy and/or Safety Tables, Listings and Figures in specified formats as per specifications and in accordance with Statistical Analysis Plan (SAP).Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health/regulatory authorities.Creation and review of programming specificationsProgramming in SAS for creation of derived data sets/ADaM as per the specification documentConstruction and building reusable standards and templatesDefining and creating training curriculum and global training plans.Guide and support team in performing statistical programming for generating tables, listings, figures.Participate in client or regulatory audits.Track & Provide status to management team on deliverables, resource utilization, productivity and quality of deliverableCoordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issuesDemonstrate and promote Cognizant global value system across all interactionsCross functional Proactively work with Statistics, data management, Medical Writing and other functions as requiired to address data issues as identified during executionProject management - Prompt study teams for potential slippagesAccountable for all deliverables (studies) on assigned Therapeutic Area/engagement, namely Responsible for quality of deliverable for assigned portfolio/TA/Segment through expert level review/QCContribute to development of TA/portolfio/Segment levels processes, guidelines as required.Participate in task forces, initiatives etc.Maintain current knowledge of statistical programming practices and developments in the industryCompliance Responsible for ensuring & mentoring teams to follows relevant SoPs / guidelines for the assigned TA/Portfolio/SegmentImprovement in productivity and identify process improvement areasProject/ Operations Management Responsibilities (as applicable)Plan and organize activities for successful delivery of the portfolio/projectOptimize resource utilization through adequate resourcing and allocationResponsible for planning, processes and key operational metrics viz. timelines, quality, efficiencyTo lead engagement level activities related to Operations, People and Client management. Prevent client escalations by timely mitigation measures for operational & people issues that may impact the targets & deliveryManage project level budgets, P&L and invoicing.Review & approve project related expenses.Contribution to business development activities RFP, bid defense, Budgets, operations setupRisk Management to maintain business continuityEnsure audit readinessLeading client or regulatory auditsStrategize and contribute towards process improvement initiatives.Team Management Responsibilities Plan and Manage timelines for assigned projects for self and team. Be responsible for day to day progress of work.Responsible for performance management of team through goal setting and periodic reviews.Identify development needs and ensure training fulfillment for the team Ensure completeness of individual training records/ log and update their training plan as per role requirement/sMentor, Coach & act as SME for team members in resolving any technical and operational issuesTo train the team members in Cognizants and/or Clients SOPs and Working Standards/ Instructions, Regulatory Guidelines, CDISC SDTM , ADaM and Define.xmlEnsure teams compliance to organizational policies and proceduresProcess Capture and analyze study team metricsContribute to Recruitment and onboarding of resourcesEnsure employee engagement and manage employee retentionContribute to Recruitment activities as required
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 10-15


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