.The Early Development & Clinical Pharmacology (ED&CP; ) Trial Manager III (TM III) 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), Standard Operating Procedures (SOPs), Health Care Compliance requirements (HCC) and local regulatory requirements.
He/she acts as the primary point of contact at a country level for assigned studies.
The TM III 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 III performs 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 III may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP; studies.
The TM III actively contributes to process improvement initiatives, training and mentoring of TMs, SMs and Clinical Trial Assistants (CTA).
Compared to a TM I and TM II, a TM III is often assigned to multi-center complex protocols and can work across Phase 0 - I studies (including FIH studies) in multiple therapeutic areas as needed to drive business needs.Principal Responsibilities Besides the LTM tasks, a TM III 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.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, country TMs (if applicable), FM, Site Strategic Lead (SSL), and other study team members to select final sites list.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.Leads and coordinates local trial team(s) activities in compliance with GCO SOPs, other procedural documents and applicable regulations.
Leads 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 trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable).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.Maintains and updates trial management systems