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Sr. Regional Systems Lead
3 mesi fa
**Job Description**:
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
The role will be collaborating with regional and country representatives under Regional Research Directors, Quality & Continuous Improvement, Regional Systems Leads (RSLs) and Business System Owners from Business Enablement Organization (BEO), Monitoring Excellence (ME), our Company's regional Research Labs Information Technology (IT) representatives and Application Management Services.
The role will be accountable to represent regional business needs relative to the implementation of technology. They will work with Global Clinical Development process owners and sub-process owners. The role will identify technology needs within the region, coordinate alignment across regions and escalate it to PMO level to create a business case for implementing technology solutions that improve process efficiency. The role will also be working across functional areas within GCTO to ensure consistent implementation of process enabling technology to meet critical Company business needs e.g., the assurance of quality and complete data in Clinical Trial Management System (CTMS). The role will work with BEO and Application Management Services (AMS) to resolve issues related to the use of technology. The role will ensure appropriate adoption and use of new solutions by supporting RSLs providing Training and Communications to end users.
**CORE Accountabilities and Duties**:
- Support the Regional Systems Leads in their assigned region (Americas, EMEA, AP/C/J) by:
- Mentoring and onboarding new Regional Systems Leads ;
- Overseeing the conduct of User Account Review process for clinical systems in their assigned region ;
- Overseeing the conduct of data compliance and clean-up activities with Clinical Systems ;
- Managing and performing root cause analysis to identify current regional process inefficiencies and how technology may enable the process to address ;
- Overseeing, with RSLs and CRDs, the networks of Systems SMEs and ensuring that support within countries and clusters is optimal, by conducting regular assessments and touchpoints with the SMEs and stakeholders ;
- Supporting RSLs to become Subject Matter Expert (SME) for all of the clinical systems being utilized by GCTO users - functionality knowledge, roles and access process, data quality/compliance needs, pain points, system issues and available workarounds, & planned enhancements.
- Connect regularly with Regional Research Directors and Regional Operations Heads to provide updates, issues, and trends ;
- Stay engaged with Regional Change Management Leads (e.g. SIP, AIM) and RSLs to ensure the system adoption in the region is optimal ;
- Partner with Regional Systems Team Lead and other Sr. RSLs to identify global trends and areas of focus for communications, training, and support to be deployed in the regions by Regional Systems Leads ;
- Identify need for communications and additional training. Work with Regional Systems Lead, BSO, and communications experts to ensure systems communications are effective, clear for local users and informative. Ensure training sessions to share new system functionality and best practices are conducted properly, as needed ;
- Drive technology/process innovation and help with innovation pilots and ultimate implementation in the region ;
- Partner with Our Company's regional IT representatives and regional GCTO staff in the identification of processes that can be improved by enabling technology ;
- Work with Regional Systems Leads, BSO and AMS teams to identify trends in Helpdesk issues that require updated training and communications.
**Experience & Skills**:
- Bachelor degree, Master degree preferred ;
- At least 10 years in clinical research/development ;
- Proficient in English language ;
- Possessing experience working with and helping end-users of our Company's Clinical Development tools ;
- Extensive knowledge of our Company's Global Clinical Development procedures (GDP) ;
- Proven ability in delivering training and presenting on our Company's systems and business processes in multi-cultural forums ;
- Demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations ;
- Being able to handle organizational complexity, ambiguity and continuous change ;
- Experience delivering training and presenting on internal systems and business processes in multi-cultural forums ;
- Demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Being able to handle organizational complexity, ambiguity and co
