at Sanofi Group in Dover, Delaware, United States
Early participation to address operational aspects in the study country strategy in partnership with relevant parties to ensure a smooth and fast path to the First Patient In: + Identifies gaps and initiates risks assessment in processes, vendors services and resources
+ Lead Country Study Set up to ensure progress according to study timelines with strategic planning
+ Review and approve the site selection reports and recommend the final list of sites selected for the study to Cluster/ CSU Head for final approval
+ Develop and initiate early recruitment and retention strategy and associated materials at local level in collaboration with respective colleagues
Lead local study management at the country level from operational point of view starting with experience sharing during feasibility process, through end of the study according to global and local study plan: + Attends feasibility meeting to collaborate with SEM and MDA to identify most probably successful sites even for feasibility process
+ Initiates early exchange with Medical Affairs to identify important sites and/or new sites
+ Participate in the study MDA handover meeting following country allocation
+ Organize the Local Kick Off Meeting with respective local study team members
+ Prepare and lead Local Investigators Meeting; Participate in the regional/global Investigator Meeting.
+ Lead set-up activities to ensure they are within agreed timelines and according to the company standards, ensure SQV and SIV readiness including proper materials, ensure proper site management, revision and closures are done according to plan.
+ Accounts for the set-up, completion, and adaptations of project management tools at country level ( CTMS , Control room…)
+ Performance of the study: drives risk assessment and develop contingency planning and risk-mitigation strategies at country level; adapt and implement the recruitment and retention plan at local level, follow and mitigate in order to reach recruitment targets within agreed timelines.
+ Aligns with Site Partnership Manager ( SPM ) on activities to engage with sites: calls & meetings for site engagement regarding site motivation and performance or other study related topics, Participate in SIVs as needed
+ Provides support to site staff and monitoring team in the conduct of clinical trials.
+ Oversees Country Supplies Strategy and Planning including assessment and mitigation of local risks
+ Anticipates and initiates requests for reimbursements in accordance with the Operational Procedure, as well as post-study access in relation to clinical trials.
Oversees Study Budget at country/cluster level and ensures optimization and appropriate management of the financial resources: + Collaborate with Start Up Strategic Manager ( SUSM ) for preparation of LSCR (local study cost request) ensuring cost optimization and appropriate projection at the beginning of the study
+ Manage and maintain Country Study Budget during course of study
+ Progress review of planned vs actual spends
+ Ensure timely escalation of issues / risks related to the country budget and initiate LSCR updates
Promote effective communication between all parties involved in the study to align common goals and define effective strategies: + Establish the local communication plan
+ Be the main link to the local monitoring team in the management of studies
+ Collaborate with Vendor Functional Line Managers ( FLM ) to drive quality and study KPIs
+ Plan / participate in study site engagement activities (i.e. Recruitment Booster calls)
+ Work closely and proactively with MDAs/SEMs early on to drive the country strategy
+ Coordinate local study team meeting at country or cluster level as applicable
+ Establish regular exchange with GBU Medical Affairs regarding trail conduct and medico-marketing activities, e.g. publications, congress symposia
+ Align on joint KOL /investigator management
Maintain Quality and Compliance through vendor oversight of all project deliverables according to project timelines and KPIs.: + Responsible for data quality, patients' safety and maintain compliance to study metrics.
+ Identify potential problems (risks) and ensure proper mitigation plans are in place (recruitment, study conduct/data quality…)
+ Ensure high quality for data collection and queries resolution at the country level, (prepares/reviews site enrollment cap increase request; Reviews and follows CAPAs raised through RBM alerts and deviation/issues reporting)
+ Quality oversight: 10% of Monitoring Visit Report Review; Site Visit for site quality oversight as appropriate
+ Ensure CRA Study Training (Initial and new CRAs during study) according with Study Training Matrix through FLMs
+ Collaborate with QL on audit and inspection related activities
+ Ensure PAI readiness within CTMS , TMF and other systems
Major Challenges/Problems may be encountered: + Planning Study start-up, anticipate implementation of protocol amendments, resulting in shifts in study timelines, recruitment and retention challenges, data management and vendor related issues.
+ Effective and proactive communication with various stakeholders can help successfully navigate these.
+ Secure study and site related business continuity on study processes, e.g., loss of site staff, natural disasters etc.
+ Escalation of delays, issues and problems to CSU and global study management accompanied by proper proposals for counter measures.
Decision Making Authority: Project related decisions such as recommendation of selected sites, plan, prepare and adapt recruitment and retention plans, budget, use of local vendors and risk management planning at the cluster/ country and site level. Contingency plans aimed to meet forecasted timelines and targets. Have Business Continuity Plan ( BCP ) in place together with Quality Lead and management. Escalate non-performance issues to line managers and/or FLMs. Provide country proposals on action and strategy plans to RSM / GSM .
Key Internal/External Relationships: INTERNAL : + Clinical Research Operations Manager ( CROM ) or equivalent (e.g., Team leader): Project level updates, issue escalation, performance review and professional development individualized.
+ Local Study Manager ( LSM ): Partnering with assigned co-LSMs or with LSMs across the CSU for best practice sharing, knowledge transfer, as needed.
+ Regional Study Manager ( RSM ) or Global Study Manager ( GSM ): Project related communications to support global study execution, as indicated.
+ Medical Advisor ( MDA ): Medical related activity for study and sites, training, , decision tree for patient identification as needed, collaboration on site identification as needed.
+ Start Up Strategy Manager ( SUSM ): study planning and preparation in terms of timelines, budget and documents for greenlight.
+ Medical Affairs colleagues form GBUs, e.g., Medical Manager, Medical Science Liaison ( MSL ): Field insights, site specific collaboration as indicated by CSU , KOL management.
+ Site Partnership Manager ( SPM ): Project related communication to implement local study strategies for recruitment, propose new and or analyze existing Partner sites, mediation on site and CSU communication.
+ Patient Recruitment & Retention Lead ( PRRL ): Project related communication to adapt, plan and implement local study strategies for recruitment and retention.
EXTERNAL : + Vendor Functional Line Managers ( FLM ): Team performance review/escalation
+ Clinical Research Associate ( CRA ): Project related site activities (monitoring, communication)
+ Clinical Project Associate ( CPA ): Administrative project support
+ Investigators, Partner sites, KOLs: Study support
+ Other Vendors for study performance
REQUIREMENTS : + Bachelor degree or higher degree in Health, Natural Sciences or eq
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