Clinical System Manager - CTMS, Open to flexible working including homeworking
5 days left
- Contract Type
Please note: This position can be virtual (REMOTE)
The primary purpose of the Clinical System Manager - CTMS is to support the Consumer Health Clinical Development team through full support of the Clinical Trial Management System (CTMS). Responsibilities include management of user requirements, system enhancements, testing, issues, and administration of master data.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following :
- Accountable for CTMS system functionality, user requirements and configuration specifications, plus identification of impacts on other components of the clinical system environment
- Provide system and administration support to business users within the CH R&D organization including Clinical Development, Medical Affairs, Regulatory, Quality and other business functions
- Work in close collaboration and coordination with eTMF business owner and other clinical system business management colleagues to provide coverage across applications and advise on impact of enhancements across the clinical systems suite
- Accountable for resolving and escalating incidents, managing user requests in collaboration with Consumer Healthcare (CH) Tech team
- Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure these are prioritized on the CTMS Backlog List, in collaboration with Tech partner
- Work in close collaboration with CH Tech during sprint and release planning, incident reviews and test execution
- Ensure data quality standards are maintained through all system versions
- Communicate important messages relevant to all levels of stakeholders, including content and plan of systems releases, issues, etc.
- Manage the preparation, maintenance and execution of test scripts as required. Work in close collaboration with Tech on implementation and testing changes, identify on candidates for automated testing, support and verify test environment preparation and confirm that acceptance criteria have been met. Ensure GCP requirements and inspection readiness are maintained and current
- Maintain systems access and assessing any impact to systems security due to the introduction of new system features. Conduct regular access management reviews to remain in compliance with corporate security policies
- Work with business process owners and vendors to identify future enhancements to be included in the product roadmap
- Responsible for supporting Audit/Assessment/Inspection readiness and lead or participate in system internal audits and/or external inspections as needed
- Provide input as SME for the development, enhancement, implementation and maintenance of all impacted written standards and required training content
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree
- 4 + years pharmaceutical industry and/or consumer goods industry knowledge and experience
- Experience in a systems operations support role within the clinical study environment
- Experience in clinical study management
- Experience with validated document management systems
- Experience with leading clinical systems
- Experience and understanding of the clinical research process and regulations, ICH GCP and GxP regarding study / systems documentation
If you have the following characteristics, it would be a plus:
- Master's degree in a science related field
- Veeva Clinical Vault experience a plus
- Track record of success in continuous improvement, innovative work practices and driving change
- Experience working within Agile delivery methodology with an understanding of the system development life cycle
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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being .
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, 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.
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.