Job title: Manager – Data Management
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Site Name: India – Karnataka – Bengaluru Posted Date: Feb 1 2022 Job Purpose: The Manager, Clinical Data Management is responsible for overseeing the end to end DS&M study related activities and is accountable for all DS&M study de
Job Description : Site Name: India – Karnataka – Bengaluru Posted Date: Feb 1 2022 Job Purpose: The Manager, Clinical Data Management is responsible for overseeing the end to end DS&M study related activities and is accountable for all DS&M study deliverables in terms of quality & delivery to plan. This role mentors other DS&M team member(s) and acts as Subject Matter Expert. Key Responsibilities: . Accountable for the end to end DS&M study related activities in terms of quality & delivery to plan which include: Electronic Case Report Form and (electronic) Diary Cards & other clinical outcome assessments Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation o Interim and final cleaned database lock Archival of all DM documents in the eTMF Archival of the study database and provision of clinical data to the study site . Accountable for one or several complex studies, and has the ability and experience to manage the delivery of any type of study (different therapeutic areas, complex/unusual early phase setting, new/unusual indication, pivotal/Phase III and efficacy studies, clinical as well as epidemiology studies) . For an in-house study, leads the day to day DS&M operational study related activities, acts as a member of the study core team and is the single point of contact for all the DM study related activities & matters . For a study outsourced through a DM Functional Service Provider (FSP) or Full Services Outsourcing (FSO), conducts & documents sponsor oversight of the end to end FSP/FSO study related activities and ensures training on the protocol to the FSP resources working on the study . Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register . Provides reports, status updates, feedback and advice to key study stakeholders on study progress. . May oversees and provides input to the development of budgets forecasts for FSP and FSO contracts. . Creates or reviews study level timelines for DM deliverables and ensures teams adhere to these . Promotes the implementation of clinical data standards to increase consistency, efficiency & productivity . Acts as the first point of escalation for all DM study issues. Understands, mediates and solves issues related to DM study deliverables and escalates as required to DM representative at Asset level . Ensures DM study deliverables are in compliance with GSK SOPs and regulatory guidelines . Develops and maintains excellent professional relationships with study team and other key stakeholders . Acts as a mentor for junior members of the DS&M team . Acts as a Subject Matter Expert supporting the implementation of new processes, data standards, trainings, systems, vendor quality assessments, audits and inspections Basic Qualifications: Bachelor’s Degree, in scientific or business discipline Clinical trial experience. Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP). Understanding of the tools of the trade, such as standards Preferred Qualifications: Post Graduate Degree in Scientific discipline( Life Science Graduate/Medical/Paramedical/Pharmacy Degree). Minimum Level of Job-Related Experience Required: . Pharma and/or CRO experience. . Understanding of disease area. . Understanding of laboratory data. . Understanding of applicable ICH/GCP regulations and applicable GSK policies and SOPs Relevant job skill or abilities required for the Job: . Experience working with global suppliers/ partnerships to ensure deliverables are to the agreed standard . Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets . Operates across a global, complex organization. Includes applying the processes, methods, tools and approaches used to facilitate data management activities, and the day-to-day running of a project or study-aligned team . Supports capability build across the function . Develops recommendations for study or project issue resolution . Builds influential networks within the organization & study team members. Uses these relationships to generate buy-in and support for the project, Data Management Plan or equivalent, to ensure mutually advantageous resources and goals . Ensure sharing of knowledge and learning with the GSK Data Management Community . Assists in operational excellence and data quality focus negotiations with vendors and strategic partners . Communicates technical topics to a non-technical audience. . Uses an extensive network within GSK and external to keep abreast of industry trends and be part of the development of those trends Certification: CCDM (if present) added advantage *LI-GSK Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. 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Location: Bangalore, Karnataka
Job date: Thu, 03 Feb 2022 23:54:06 GMT
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