DOCS Senior Trial Manager ED&CP *** PARIS *** Top Pharmaceutical company in France
Senior Trial Manager ED&CP * PARIS * Top Pharmaceutical company
Ref #: 29696
Employment type: Permanent - Full-Time
Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM.
Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
* Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
* 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.
- 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 Sharepoints). 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 study management teams.
* Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget.
- Adheres to finance reporting deliverables and 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
* May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget.
* Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs.
* A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
* Minimum six years of pharmaceutical and/or clinical trial experience is preferred. 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.
* Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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