Beschreibung
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 scope of SMT in support of continuous improvement and rigorous execution of clinical trials. Accountable to, and partners with the SMT and relevant 3rd parties to lead, direct, and efficiently deliver clinical systems and innovative solutions, in support of clinical trials.General Information:
- Start date: asap
- End date: 1 year duration
- Work location: Basel
- Workload: 100%
- Team: About 6 people in the team
Tasks & Responsibilities:
• Manages the end-to-end lifecycle of applicable clinical systems needed for a given study, including requirements gathering and reviewing, testing, deployment, maintenance, and closeout.
• Understands business context and SMT goals to effectively partner with and continually assesses the needs of the SMT, to proactively translate business needs into system and process improvements.
• Serves 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. Mastery of PDG’s clinical trial end-to-end processes & services, so as to enable proactive consultation on complex and/or novel clinical trial design and execution.
• Identifies process inefficiencies and compliance gaps, participates in process improvement initiatives and drives process implementation in support of SMTs.
• Ensures prompt resolution of system issues, and provides timely and accurate responses to customers, as defined in service level agreements. Understands and proficient in PDG system landscape and applicable integrations.
• Track and analyse key systems performance indicators (KPIs) and contributes to analysis to identify root causes for defects, to recommend process and/or system improvements.
Must haves:
• Clinical operations experience*
• Project and vendor management experience (for vendor management it can be someone from a vendor interacting with sponsor or the other way around)*
• 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 and minimum Bachelor degree*
• Knowledgeable with the processes and principles of program and customer relationship management, and business analysis.
• Experience managing third party vendors in delivering quality service as expected.
• Ability 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.
• Ability to see and anticipate the interrelationship of systems and procedures within a project and understand their interdependencies – Systems thinking.
Nice to haves:
• Project Management Certification