Study Delivery Lead

  Regulatory Affairs

Job title: Study Delivery Lead

Company: GlaxoSmithKline Pte Ltd

Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jan 20 2022 Are you looking for an opportunity to share your knowledge of how evidence generation and research studies are conducted, reported, and published? If so, this is the r

Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jan 20 2022 Are you looking for an opportunity to share your knowledge of how evidence generation and research studies are conducted, reported, and published? If so, this is the role for you. This job within VEO Study Delivery and Quality Operations combines end-to-end design, execution, and reporting of clinical studies and trials as well as supporting the delivery of VEO activities including: Non-interventional studies using primary data collection, including prospective studies enrolling patients and or/HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g. with EMRs/chart abstraction), patient reported outcomes development and validation Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilization studies, prevalence/incidence studies of exposure, risk factors, and outcomes Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients VEO activities in support of evidence generation (e.g. literature review, external scientific advice, feasibility assessments) This role works across therapy areas (Oncology, Specialty & Primary Care, Vaccine) and includes responsibility and/or accountability for the set-up, coordination, execution, and delivery of the VEO and vaccine portfolio in partnership with the Science Lead: Planning and leading the delivery of VEO studies to time, quality, budget, company standards, and scientific requirements from concept protocol to final study report. Leadership of a multifunctional matrix team to ensure study oversight, study delivery, and takes operational decisions at the study level. Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents, and Clinical Study Reports. Accountable for the study delivery strategy and Study Management Plan as applicable (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools, etc.) Responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors. The SDL ensures appropriate training of country staff, vendors, and sites on protocol and project-specific matters – prepare/deliver monitors meeting (when applicable) Ensure compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies. Work with matrix partners, Senior Study Delivery Lead, and/or manager to develop and manage study level budget within project budget allocation Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills Co-ordination and delivery of outsourced VEO activities in support of evidence generation (e.g. literature review, external scientific advice, feasibility assessments) Manage, in collaboration with Study Delivery Associates (SDA) and Procurement, RFP, proposal, purchase order requesting, and contract execution aspects of the activities and liaise with vendors. Ensure activities are registered correctly in GSK enterprise systems, in collaboration with central business groups supporting those systems and processes and with other members of VEO Business Operations Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in business, science, medicine, engineering, finance, or honors degree Minimum of 8 years’ experience in clinical project or alliance management with proven skills Experience in health outcomes research, patient-reported outcomes, or epidemiology. Demonstrated hands-on clinical operations experience preferably across a range of therapeutic areas and/or study types Experience in developing and contributing to study protocols, study procedure manuals, informed consent forms, clinical study reports, and manuscripts Experience in vendor oversight and relationship management etc. Knowledge of the principles of quality, safety, risk management, and compliance (ICH and GCP) Demonstrated ability to create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring Excellent communication skills including verbal and written communications, with the ability to present to internal department meetings and external advisory/investigator meetings. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. 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. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 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Expected salary:

Location: Bangalore, Karnataka

Job date: Sat, 22 Jan 2022 23:32:43 GMT

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