Senior Trial Manager Ed&cp - Issy-les-Moulineaux, France - Johnson & Johnson

Johnson & Johnson

Entreprise vérifiée

Issy-les-Moulineaux, France

il y a 2 semaines

Posté par:

Sophie Dupont

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Description

Working with Johnson & Johnson can change everything. Including YOU.

We are recruiting a
Senior Trial Manager Early Development & Clinical Pharmacology (ED&CP) within our Global Clinical Operations (GCO) at Johnson & Johnson.

In this role you will be 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.

You will act as the primary point of contact at a country level for assigned studies.

You will perform 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.

You will 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.

You may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies.
You will actively contribute 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.

Your key 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 followup of pretrial 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. Uses study tools and management reports/dashboards available to analyse trial progress
Monitors country and overall study progress (if applicable) and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to GPL, GTL and study management teams e.g., ensures appropriate documentation and followup 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 assist Contract and Compliance Services (CCS) for negotiation of trial site contracts and budget. Is responsible or collaborates with Clinical Forecasting & Analytics 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 setup and conduct of Investigator Meetings (either local or multicountry) if applicable and collaborates with SM for site initiation visits.
Conducts trial team meetings and provides or facilitates TM/SM training when needed and builds key competencies (i.e., implementation of study amendmentand changes in study related processes).
Reviews and approves Visit Reports submitted by SM within procedural timelines; identifies issues and/or trends across a trial/project and escalates deviation/issues to the GTL and FM as needed. Supports implementation of ARBM (Analytical riskbased monitoring) model as applicable.
Supports SM in setting up action plan in case data entry timelines are not respected.
Ensures coordination of study supplies at country level or study level as applicable and ensures that clinical drug supplies are appropriately handled, administered and stored in strict adherence with investigational product preparation and administration guidelines in collaborat