.Global Clinical Operations (GCO)ED&CP Trial Manager II*(*Title may vary based on Region or Country requirements)Position Summary:The Early Development & Clinical Pharmacology (ED&CP) Trial Manager II (TM II) is responsible for the local management of a trial in one or more countries and to deliver quality data and trial documents/records that are compliant with assigned clinical protocol, codes of Good Clinical Practice (GCP), Healthcare Compliance Requirements (HCC), Standard Operating Procedures (SOPs) and local regulatory requirements.He/she acts as the primary point of contact at a country level for assigned studies.The TM II performs the Local Trial Manager (LTM) tasks including operational oversight of assigned protocol(s) from start-up to database lock and closeout activities as described in GCO procedural documents.The TM II may perform the Global Trial Leader (GTL) tasks as described in GCO procedural documents for ED&CP studies which follow the ED&CP hybrid oversight model.The TM II may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies.The TM II actively contributes to process improvement initiatives, and training and mentoring of SMs and Clinical Trial Assistants (CTA).Principal Responsibilities:1 Besides the LTM tasks, a TM II may also be responsible for GTL and SM tasks depending on the studies assigned. For the GTL and SM tasks reference is made to the Job Description for the ED&CP GTL and SM and the GCO Procedural Documents.2 Collaborates with the FM for performing study feasibility and site assessments, providing recommendation of suitable sites for selection to participate in the trial according to ED&CP decision tree. Ensures appropriate follow-up of pre-trial visit activities. Collaborates with the GPL (Global Program Leader), GTL, FM, Site Strategic Lead (SSL), and other study team members to select final sites list.3 Contributes to the development of study management documents at a country level or initiates development of these documents for trials which follow ED&CP Hybrid Oversight Model.4 Leads and coordinates local trial team(s) activities in compliance with GCO SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable).5 Ensures that all Serious Adverse Events (SAE)/Product Quality Complaints (PQC)/ Suspected Unexpected Serious Adverse Reactions (SUSAR) are reported within reporting timelines and documented as appropriate.6 Maintains and updates trial management systems. Uses study tools and management reports/dashboards available to analyse trial progress
