MAJOR DUTIES & RESPONSIBILITIES: Briefly describe the major duties and responsibilities for which the job is held accountable (what the job does, why is it done/impact)
1. Oversight of the study at regional level to ensure progress according to study timelines:
Is accountable for all countries allocated in a region for the following:
planning, set-up activities within agreed timelines and according to the company standards, performance of study (reaching recruitment targets within agreed timelines), anticipation and implementation of action plans related to study performance/ data quality, contribute to patient data review and surveillance plans, responsible for data validation, ensure site closures are done according to plan and archiving is finalized.
2. Participate to core trial team meetings (CTTs)
Organizes/ conduct kick-off meeting with countrie’s Local Clinical Project Leaders (CPLs) and local monitoring teams (MTs).
Organizes training of monitoring teams (study procedures, study devices, monitoring plan,…).
Organize/conduct regional investigators meetings/co-organizes local investigators meetings as applicable.
Provides support to MTs (protocol, monitoring plan, CRF, tools…)
Organize/conduct Regional CTT
Contribute to data review meetings & medical review meetings
3.Supervises the preparation of local study AEDs within/across countries from the allocated regions, and ensures optimization of costs.
Ensure follow-up of study budget
Ensures the implementation of IT systems in the countries (IVRS, ePortal)
Ensures adequate provisioning of devices and materials in the countries
Participates in the revision/preparation of study progress tools (newsletters,…)
Ensure regular project reports are available.
4. From available reports and metrics, ensure study is conducted in compliance with all study plans Monitoring, DMP, DVP…)
Ensure overall monitoring quality by evaluating reports from CTMS, detecting issues and escalating issues reported by CPLs (country CPLs responsible for MVRs)
Regular contact with country CPLs and monitoring teams (regional CTT).
Analyse risk and anticipate/identify potential problems; ensure they are mitigated/solved with robust action plans in place as agreed with CTOM (recruitment, study conduct, data quality).
Ensures high quality level in data collection and queries resolution for the region.
Perform patient data validation homogeneously and fulfilling required quality standards and giving input to coding reviews.
Ensure study documentation is properly maintained and archived in e-TMF, e-rooms and databases as applicable for the allocated countries.
5. Ensure regional site closure plan is followed and archiving in region is done.
Ensure preparation and proper response to audit/inspection reports and implementation of recommendations.
Provide oversight at regional level for Regulatory (RA) pre-approval inspections.
Shares lessons learned and ensures adequate deployment of possible identified action plans for improvement within/across the region.
6. At times of reduced workload at regional level and/or as required by the company, the RTM will assume local CSU CPL activity for an interim period.
Knowledge And Skills:
1) Knowledge of GCP/ICH phase I-IV clinical trials.
Strong Project Management skills, leadership, communication (verbal & written) skills, organizational, presentation skills, analytical and planning abilities, results oriented, quality preserving, be proactive and able to anticipate and resolve conflicts/issues (i.e. decision making & problem solving skills), reactivity to emergent needs, able to handle & prioritize multiple tasks, time management.
Understand and is sensitive including experience with intercultural differences.
Open to international mobility.
Strong English skills (verbal and written if English is the second language)
Ability to adapt and be flexible to change and managing internal and external impediments
Knowledge or ability to rapidly gain knowledge with programming/query languages
Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools, processes and QDs
Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc)
Team work skills
Ability to work autonomously and to efficiently & effectively provide status reports
Formal Education And Experience Required:
University degree in Health Sciences or equivalent
Minimum of 6 years of experience in clinical research
Previous experience as Clinical Project Leader managing more than one country
Formal training or certificate on Project Management
Fluent in English.
Knowledge And Skills Desirable But Not Essential:
International experience working with teams abroad
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
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