Site Name: Belgium-Wavre, Italy - Siena, Netherlands - Amsterdam
Posted Date: Mar 26 2021
The final candidate may be based in either one of the following three locations: Belgium - Wavre, Italy - Siena, Amsterdam - Netherlands.
As the Senior Data Standards Manager, you will lead cross-functional teams to maintain and improve the global data standards ensuring standard innovation, compliance and strategic alignment with Standard Governance for CEG.
This role ensures data standards are of top industry and scientific quality and used across preclinical, clinical and epidemiological studies.
Your responsibilities will cover the following:
- Lead cross-functional teams and working groups to manage and improve the global data standards used across preclinical, clinical and epidemiological studies. The data standards include eCRFs with associated edit checks and form navigation scripts, underlying EDC database structure, trial design metadata and CDASH to SDTM (Submission Data Tabulation Model) mappings.
- Ensure strategic alignment with Standard Governance acting as a primary point of contact for data standards within the organization.
- Supervise collaboration between data management, R&D centres, Regions and approve per trial data collection worksheets (i.e. CRF Specification document).
- Provides impact assessments and recommendations for non-standard requests and standard updates.
- Act as a member of the Data Standards related governance boards and lead discussions on study-specific deviations from Standard in the Data Standards related governance board.
- Responsible for effective governance of the GSK Vaccines database standards, and metadata standards.
- Provide the datasets and supporting documents (e.g. Define.xml, Reviewers Guide) for CDISC submissions in collaboration with the study team.
- Process owner or delegate of data and metadata standards governance process such as SOPs and Work Instructions (WIs).
- May act as Subject Matter Experts in supporting Business Excellence in the implementation of new processes, training, systems, vendor quality assessments, audits and inspections.
We are looking for professionals with these required skills to achieve our goals:
- University Degree - Master's or equivalent experience in Engineering, Life Sciences, Computer Sciences, Mathematics and Physics.
- Minimum 5 years in Clinical Research with experience in managing CDISC compliant Data Standards.
- Experience required to deliver the implementation, update and enforcement of data standards in-line with expectations in terms of time and cost and in compliance with DSCS processes.
- Experience required to challenge and improve the processes around data standards.
- Good analytical skills.
- Good communication and presentation skills, ability to facilitate interfaces within extended network, proven experience in negotiating and influencing at different levels of the organization in a matrix environment.
- Experienced in leading improvement initiatives from inception through to completion involving both multi-disciplinary and geographically remote partners.
- Excellent knowledge of CDISC standards (CDASH, SDTM, ADaM).
- Experienced in Data Management.
- Basic understanding of Clinical programming (ex: SAS or other).
- Good computer skills.
- Good understanding of regulations including ICH-GCP.
- Fluent English (spoken and written); French and Italian a plus.
If you have the following characteristics it would be a plus:
- Ability to apply knowledge to manage complex processes and systems in the pharmaceutical industry.
- Strong matrix leadership skills.
- Attention to detail, conscientious and accurate.
- Good organizational, planning and time management skills.
- Good problem-solving skills.
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 in a culture of Innovation, Performance and Trust.
GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
For further information, please visit www.gsk.com .
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
At GSK we value diversity 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.
We provide a supportive working environment and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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.
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