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11965en
- Contract
- English
- Mid-Senior level
- Research & Development
- Basel
- Healthcare & Life Sciences
Skills
Clinical Operations, Clinical Systems, IxRS, eCOA
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For our client, one of the leading Healthcare & Life Sciences companies based in Basel, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Systems Implementation Leader. This is a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
Systems Implementation Leader
Duration: 6 months
The Systems Implementation Leader (SIL) will serve as the primary point of contact and business partner for PDG Study Management Teams (SMTs) for all clinical systems and services that Systems and Process Excellence (SPE) offer. SIL will be accountable for the setup, implementation and operations of the PDG suite of clinical operations systems, such as IxRS and eCOA.
Your Mission:
• Managing the end-to-end lifecycle of applicable clinical systems needed for a given study, including requirements gathering and reviewing, testing, deployment, maintenance, and closeout.
• Partnering with and continually assessesing the needs of the SMT, to proactively translate business needs into system and process improvements.
• Serving as first line of contact for triaging all SMT support and service requests for each clinical study.
• Identifying process inefficiencies and compliance gaps, participating in process improvement initiatives and driving process implementation in support of SMTs.
• Ensuring prompt resolution of system issues, and providing timely and accurate responses to customers, as defined in service level agreements.
• Tracking and analysing key systems performance indicators (KPIs) and contributing to analysis to identify root causes for defects, to recommend process and/or system improvements.
Your Profile:
• Clinical operations experience
• Project and vendor management experience
• Working experience with Clinical Operations and Information Systems and processes such as IxRS, eCOA, RBM, CTMS, eTMF, EDC and Clinical Supply Systems
• Bachelor degree and minimum 5 years of relevant experience in Pharma
• Knowledgeable with the processes and principles of program and customer relationship management, and business analysis.
• Experience managing third party vendors.
• Leadership experience.
• Up-to-date knowledge of clinical operations processes and information systems.
Systems Implementation Leader
Duration: 6 months
The Systems Implementation Leader (SIL) will serve as the primary point of contact and business partner for PDG Study Management Teams (SMTs) for all clinical systems and services that Systems and Process Excellence (SPE) offer. SIL will be accountable for the setup, implementation and operations of the PDG suite of clinical operations systems, such as IxRS and eCOA.
Your Mission:
• Managing the end-to-end lifecycle of applicable clinical systems needed for a given study, including requirements gathering and reviewing, testing, deployment, maintenance, and closeout.
• Partnering with and continually assessesing the needs of the SMT, to proactively translate business needs into system and process improvements.
• Serving as first line of contact for triaging all SMT support and service requests for each clinical study.
• Identifying process inefficiencies and compliance gaps, participating in process improvement initiatives and driving process implementation in support of SMTs.
• Ensuring prompt resolution of system issues, and providing timely and accurate responses to customers, as defined in service level agreements.
• Tracking and analysing key systems performance indicators (KPIs) and contributing to analysis to identify root causes for defects, to recommend process and/or system improvements.
Your Profile:
• Clinical operations experience
• Project and vendor management experience
• Working experience with Clinical Operations and Information Systems and processes such as IxRS, eCOA, RBM, CTMS, eTMF, EDC and Clinical Supply Systems
• Bachelor degree and minimum 5 years of relevant experience in Pharma
• Knowledgeable with the processes and principles of program and customer relationship management, and business analysis.
• Experience managing third party vendors.
• Leadership experience.
• Up-to-date knowledge of clinical operations processes and information systems.