Senior Project Lead - Data Acquisition Standards

Site Name: Bengaluru Luxor North Tower Posted Date: Nov 21 2022 A healthier planet starts with healthier people 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Proposed Job Title - Senior Project Lead - Data Acquisition Standards Job Purpose - This role is primarily responsible to develop and maintain above studies data acquisition standards library and the supporting standard data flow. Key Responsibilities:- • Collaborate with cross-functional teams and working groups to develop global Electronic Data Capture (eDC) standards as well as standards for other types of Data Acquisition instruments where applicable making sure they are aligned. • Set-up new Electronic Data Capture (eDC) data standards requirements and manage standardization activities. • Ensure alignment with other departments acting as primary point of contact for data standards within the organization. • Provide impact assessments and recommendations for data standards requests from Therapeutic Area project teams with a focus to accelerate development & process improvement. • Act as a member of the Data Standards related governance bodies and drive discussions on data standards. • Responsible for effective governance of the GSK Therapeutic area database standards, and metadata standards library. • Provide study data requirements for CDISC submissions and review study data set-up deliverables and study data submission packages. • Provide input for data standards related written standards SOP (Standard Operating Procedures) and WIs (Work Instructions). • Perform and/or oversee system/database administration for the global Data Repository/Clinical Oracle database. This includes: − Operational and user support for the global Data Repository / Clinical Oracle database and the interfaces between the systems. − Interact with IT (Information Technology), Clinical Systems team and the vendors that are hosting and/or supporting the applications. − Maintain the global Data standards eDC database and associated central metadata and support development of CDISC standards. − Maintain databases security/integrity. Knowledge/Education Required:- Minimum Level of Education - Bachelor’s Degree in Sciences (or above), or equivalent functional industry experience Preferred Level of Education - Master’s Degree in Sciences Area of Specialization - Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent Minimum Level of Job-Related Experience Required :- • Minimum 2 years Clinical Research or Information Systems or relevant scientific experience and demonstrated good collaboration and communication skills. Job-Related Experience sections above that are required for the job:- Language skills: • Fluent English language (spoken and written) • French language and Italian language known is a plus Soft skills: • Strong analytical skills • Effective communication and presentations skills, ability to facilitate interfaces within extended network, proven experience in negotiating and influencing at various levels of the organization in a matrix environment • Strong problem solving and project delivery skills • Able to build good working relationships virtually and face to face • Attention to detail, conscientious and accurate • Good organizational, planning and time management skills Hard skills: • Experienced in Clinical Data Management or Clinical Programming • Excellent computer skills, understands interfaces and data flow • Expert skill set for Clinical systems administration and security maintenance • Good programming skills required (e.g., SAS, SQL, Cognos), skills with other relevant tools are desired • Good understanding of clinical data and CDISC • Knowledge of CDISC standards (CDASH, SDTM, ADaM) • Strong understanding of regulations including ICH-GCP • Experience working in database systems and environments • Understanding of general data flow & database architecture concepts • Expertise in eDC solutions (Inform, Rave, Veeva CDMS Vault) At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. *LI-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.