Trial Manager EDCP

Job description

The Early Development & Clinical Pharmacology (ED&CP) Trial Manager (TM) 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 protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
He/she acts as the primary point of contact at a country level for assigned studies.
The TM 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 performs the Global Trial Manager (GTM) tasks as described in GCO procedural documents for ED&CP studies to which no GTM has been assigned.
The TM may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies.
The TM actively contributes to process improvement initiatives, and training and mentoring of Site Managers and Clinical Trial Assistants.

Principal Responsibilities
·  Besides the LTM tasks, a TM may also be responsible for GTM and SM tasks depending on the studies assigned. For the GTM and SM tasks reference is made to the Job Description for the ED&CP GTM and SM and the GCO Procedural Documents.
·  Is responsible for study feasibility and site/lab assessments, providing recommendation of suitable sites for selection to participate in the trial. Ensures appropriate follow-up of pre-trial visit report.
·  Collaborates with the CPL, GTM, functional management and Protocol Owner to select final site list.
·  Contributes input to the development of e.g. the Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for trials to which no GTM is assigned.
·  Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) 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).
·  Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
·  Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and SharePoint sites). Uses study tools and management reports available to analyze trial progress.
·  Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to CPL,GTM, protocol owner and study management teams e.g. ensures appropriate documentation and follow-up related to protocol issue escalation.
·  May submit requests for vendor services and may support vendor selection. Reviews and approves site and local vendor invoices as required
·  May lead negotiation of trial site contracts and budgets. May be responsible for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting deliverables and timelines.
·  Accountable for set-up and conduct of Investigator Meetings.
·  Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
·  Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed.
·  Reviews and approves site and local vendor invoices as required.
·  Works with SM to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits
·  Complies with relevant training requirements.
·  Acts as expert for assigned protocols. Develops therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
·  Acts as primary local contact in GCO for a trial. Establishes and maintains excellent working relationships with GTM, external stakeholders, in particular investigators, trial coordinators, other site staff, key contacts in Early Development and/or Clinical Pharmacology and other internal stakeholders.
·  Actively contributes to process improvement initiatives, and training and mentoring of Site Managers and Clinical Trial Assistants.

Desired profile

4-year University degree in Life Sciences, Nursing, or related scientific field is required.

Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.

Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills.
Willingness to travel with occasional/regular overnight stay away from home depending on the region.
Flexible mindset and ability to work at a fast pace within small exploratory study teams
Ability to work on multiple trials in parallel in different disease areas