Principal Project Lead, Data Acquisition Standards
2 weeks ago
**Site Name**: USA - Pennsylvania - Upper Providence, Canada - Ontario - Mississauga
**Posted Date**: Jan 19 2023
Are you looking for an opportunity to manage clinical data projects and meet study objectives? If so, this is the role for you.
As Principal Project Lead, Data Acquisition Standards you will manage/lead/be responsible for
The technical development and maintenance of Electronic Data Capture (eDC) for global standards. This role defines, governs, and implements Data Standards to facilitate above studies data acquisition standards library e.g., EDC Library development and maintenance, provide training/communication for users and acts as Subject Matter Expert.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead cross-functional teams and working groups to manage and improve the global data standards library used for pipeline delivery mainly for CDASH, to align with SDTM, Controlled Terminology and Value Level Definition, and the raw data to SDTM mappings.
- Act as a primary point of contact for data acquisition standards within the organization and ensure strategic alignment with Standard Governance.
- Supervise collaboration with stakeholders and provide expertise and consultancy.
- Provides impact assessments and recommendations for non-Standard requests and Standard updates.
- Provides Standards consultancy to business functions on demand including core, therapeutic Standards and develop Data Standards contents.
- Guide the study team and lead discussion on study specific deviations from Standard.
- Responsible for effective governance and project delivery of the GSK end-to-end Standards.
- Maintain the Standards templates and supporting documents for CDISC submissions in collaboration with the stakeholders.
- Contributes to development of Standards related process documentation, e.g., SOPs (Standard Operating Procedures), Working Instructions, Best Practice, Template etc.
- May act as Subject Matter Expert in the implementation of new processes, trainings, systems, vendor quality assessments, audits, and inspections.
- Acts as a mentor for junior members of the Data Standards team.
- Manage the development of systems and tools internally and externally to ensure they are fit for purpose.
**Why You?**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s Degree in Sciences or above, or equivalent functional industry experience
- Clinical Research with experience in managing CDISC compliant eDC Data Standards
- Excellent expertise in eDC solutions (Inform, Rave, Veeva CDMS)
- Excellent knowledge of CDISC standards (CDASH, SDTM, ADaM)
- Experience in Clinical Data Management or Clinical Programming
- Experience working in database systems and environments
- Basic understanding of programming e.g., SAS
- Good understanding of regulations including ICH-GCP.
- Understanding of general data flow & database architecture concepts
- Proven ability to clearly convey information orally and in writing (technical documentation, presentations to business stakeholders, etc.) to audiences with varied and sometimes limited technical knowledge.
- Fluent English language (spoken and written)
- Effective communication and presentations skills
- Team spirit - Ability to facilitate interfaces within extended network
- Proven experience in negotiating and influencing at various levels of the organization in a matrix environment.
- Attention to detail, conscientious and accurate
- Excellent record of customer focus, influence, delivery, innovation, follow through and acting as a catalyst for change.
- Experience in leading improvement initiatives from inception through to completion involving both multi-disciplinary and geographically remote partners.
**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:
- Master’s Degree in Sciences
- Programming or data science experience is preferable with background.
- Excellent computer skills, understands interfaces and data flow are preferable
- 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
- Strong matrix leadership skills
- Strong analytical skills and project management skills
- Good organizational, planning and time management skills
- Problem-solving skills ability
**Why 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 organization 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 1
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