Systems Implementation Leader - IXRS
Client: Pharmaceutical Multinational
Location: Basel, Switzerland
The Systems Implementation Leader (SIL) serves 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. SILs are accountable for the setup, implementation and operations of the PDG suite of clinical operations systems, such as IxRS and eCOA. SILs have a high degree of expertise in customer relationship management, e2e study management processes and systems, and vendor management. By partnering with SMTs, the Systems Implementation Leader identifies new opportunities within the scope of SMT in support of continuous improvement and rigorous execution of clinical trials. Accountable to and partnering with the SMT and relevant 3rd parties to lead, direct, and efficiently deliver clinical systems and innovative solutions, in support of clinical trials. The ideal candidate is NOT a technical / programming profile. Instead they should be someone who liaises with the study management team and has clinical operations experience, project & vendor management skills and with experience of both IxRS, eCOA & CTMS (IxRS in particular - rather than eCOA)
*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
*Understanding business context and SMT goals to effectively partner with and continually assess 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 Expert in all SPE support and service catalogue, so as to enable rapid and focused decision-making or issue resolution
*Clinical operations experience
*Project and/or 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 (emphasis on IxRS)
*Overall 5 years with relevant experience (clinical operations, system management etc) in pharma with a minimum bachelor's degree level
*Knowledgeable with the processes and principles of program and customer relationship management, and business analysis.
*Experience in managing third party vendors in delivering quality service as expected.
*Able to successfully lead teams or change initiatives through implementation with little or no oversight. Proven as a successful decisive leader in a strategic multifunctional environment, with proven ability to navigate organizational complexities
*Up to date knowledge of clinical operations processes and information systems. Understanding of internal/external system landscape.
*Able to see and anticipate the interrelationship of systems and procedures within a project and understand their interdependencies - Systems thinking.
*A Project Management Certification is a bonus but not essential
Please contact Justin Rose, Clinical Research Recruiter on
Tel: +44 1727 817655 or email: firstname.lastname@example.org