Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Aug 24 2022
Is there any greater challenge than getting ahead of disease? 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. Job Purpose:-
This role is primarily responsible for data acquisition applications for clinical studies across Therapy Areas comply with company and industry standards, concerning quality and timelines. This role may have supervisory responsibility and/or oversight for a small team.
Key Responsibilities:-

• Lead/Responsible for the study set-up, technical development of Electronic Data capture (eDC) solutions and associated tools for one or more clinical study(ies).
• Responsible for project delivery of multiple Clinical studies for all clinical data acquisition activities, including timeline management, oversight/governance of external vendors, driving team members to meet project timelines, etc.
• For studies, key responsibilites include:

o Act as an advisor for the Study Core Teams (SCT) members in providing DM operational/requirements about the eDC study set-up or vendor technical related activities
o Provides input to study design, the clinical protocol, study planning and review of study documents as appropriate.
o Coordinates review, revision, and approval of study specification documents (including operational requirements & specifications) and/or key vendor deliverables (including translations)
o Understands, mediates, and solves issues related to Data acquisition and escalates as appropriate to the Study Data Manager or Vendor
o Develops the study eDC application and associated documents including forms, data validation checks & data extraction and ensures delivery with quality and on time
o Provides reports, status updates, feedback, and raises risks and advice to Study Data Manager about study set-up and/or vendor related activities
o Ensures quality control of deliverables
o Responsible for performing after-action reviews (success or failure) to share learnings and propose improvements for the future.

• Acts as a Subject Matter Expert for core Data Acquisition activities like process improvements, new processes, training, quality assessments, audits and inspections.
• Acts as a mentor in their expertise area to shorten the learning curve of the more junior profiles and act as a reference model within the Data Acquisition team. AND Responsible for building capability, leading, and mentoring junior team members.
• As required, may have line management responsibilities for a small team.Adhere to the relevant departmental SOPs, corporate policies, regulatory requirements and industry best practices.
• When studies are outsourced either through an e2e DM FSP model or through FSO, supports the Study Data Manager & Oversight Data Manager in specific ePRO, eCOA, and other external vendor data matters or issues.

Number of Direct Reports - 0 to 8 Knowledge/Education Required:- Minimum Level of Education Required - Bachelors or equivalent Preferred Level of Education - Masters Area of Specialization - Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent Previous Experience Required:- Minimum Level of Job-Related Experience Required - 8+ years of experience in data acquisition or related job experience in Clinical Research or Information Systems and/or relevant scientific experience.
2+ Project Management and/or People management experience with direct/indirect reporting is preferred. Job-Related Experience sections above that are required for the job:-
Soft skills

• Excellent communication skills within a matrix environment
• Presentation & training skills
• Good analytical, problem solving and project delivery skills
• Fluent English (written and spoken)
• Team spirit – ability to facilitate interfaces within extended network
• Good time management skills: ability to manage time and priorities
• Ability to anticipate for changes and be flexible in their implementation
• Problem solving mindset
• Quick learner
• Ability to handle technical and complex topics
• Proactive, flexible and stress resistant
• Results oriented and customer focused
• Willing to work in an international environment
• Capable to manage planning conflicts with a high level of complexity during multi-disciplinary meetings when participants have different concerns and to propose pragmatic solutions.
• Innovative/Flexible thinking, process minded, keeping openness for specific project needs
• Strong ability to mentor teams

Hard skills

• Experienced in Data Management in the pharmaceutical industry
• Experience with SDTM CDISC standards
• CDISC Knowledge
• Knowledge of multiple programming languages (PL/SQL, SAS, Python, C#, etc.)
• Experience working in database systems and environments, including Oracle and Unix
• Understanding of general data flow & database architecture concepts
• Good understanding of regulations including ICH-GCP
• Ability to explain complex technical principles to non-technical staff
• Experience developing programmatic transformations of clinical laboratory data
• Knowledge of medical terminology related to biospecimen collection and assessment
• Expertise in eDC solutions (Inform, Rave, Veeva CDMS Vault) and ePro solutions
• Experience of managing business remotely in a matrix network

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 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.

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