Site Name:
UK – London – New Oxford Street, Warsaw Posted Date:
Jan 21 2025 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. As a Clinical Data Manager, you will be responsible for overseeing the end-to-end DS&M study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan. 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, vendor data, and other clinical outcome assessments Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation 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 Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register 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 Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s Degree in scientific or business discipline Experienced in Clinical Data Management processes, standards and clinical systems Project Management experience Understanding of general data flow & database architecture concepts Comprehensive understanding of clinical drug /Vaccine development process Knowledge of medical terminology, anatomy and physiology Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Proven ability to prioritize and multi-task, along with effective time management skills Detail oriented, organized Excellent interpersonal and teamwork skills Demonstrates adaptability and an agile mindset Exposure to InForm, Rave/ Veeva/ OC, e-Diaries, e-Source is an added advantage Closing Date for Applications – Tuesday 4th of February 2025 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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UK – London – New Oxford Street, Warsaw Posted Date:
Jan 21 2025 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. As a Clinical Data Manager, you will be responsible for overseeing the end-to-end DS&M study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan. 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, vendor data, and other clinical outcome assessments Defining and executing the Data Management Strategy including data ingestion, cleaning & reconciliation 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 Provides DM operational input into the study design, the protocol, study planning, study documents including the study risk register 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 Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s Degree in scientific or business discipline Experienced in Clinical Data Management processes, standards and clinical systems Project Management experience Understanding of general data flow & database architecture concepts Comprehensive understanding of clinical drug /Vaccine development process Knowledge of medical terminology, anatomy and physiology Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Proven ability to prioritize and multi-task, along with effective time management skills Detail oriented, organized Excellent interpersonal and teamwork skills Demonstrates adaptability and an agile mindset Exposure to InForm, Rave/ Veeva/ OC, e-Diaries, e-Source is an added advantage Closing Date for Applications – Tuesday 4th of February 2025 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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