Fainda Sidibe Email & Phone Number

Boudry, Neuchâtel, Suisse

Audit CAPA response supportTraining Process ImprovementCompliance Assessment

Boudry, Neuchâtel, Suisse

Neuchâtel Area, Switzerland

Marin Switzerland

Project Management :• Provide operational input on development, management and maintenance of study deliverables through collaboration with internal and external stakeholders• Use performace metrics and quality indicators to assist the clinical trial manager in driving study execution• Lead/Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans• Support Health Authority inspections and CQA audits as required• Ensure full compliance (completeness and accuracy) of required data in study management tools including CTMS, patient enrollment forecasting, etc• Develop and maintain collaborative relationships with internal and external partners/stakeholders• Review documents including essential documents and submit documents to appropriate departmentStudy Planning and Conduct• Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution• Participate in vendor specification development and management/oversight• Manage TMF set up, ongoing quality review and final reconciliation• Reconcile IP at study level in collaboration with IMSC• Actively contribute to study meetings including presentation• Contribute to development/coordination of study training for study team, investigational sites and vendors• Contribute to oversight of the required country regulatory and country/site IRB/IEC approvals/notifications• Assist with the collection of various study documents such as country/insurance, CSR appendices, etcFinancial Planning and Management• Manage vendor and site payment processing and tracking• Assist with maintenance of study budget tracking tools and reconcile invoices with overall contract/budget and finance reports

Support Study Team to select potential investigator and assess their interest in the studyProcess drug shipments after gathering necessary essential documents and track receipt of shipmentsHave a significant role in managing the study documentation including responsibility for :• Distribute and, at times, create study documents and submit documents to appropriate departments such as IMSC, Regulatory Affairs• Review documents including essential documents and submit documents to appropriate department• Performing QC of TMF as appropriateAssist with generating the CSR Appendices and participate in SOP and WP developmentMentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiativesTrack Study Progress in CTMS including patient enrolment and patient status and milestonesProcess and track payments to vendor and study sites as appropriateHave a significant role in managing the study documentation including responsibility for :• Maintain and Track documents such as IB, insurance policies, protocol amendment submission…• Support the Study Manager in creating, updating and tracking study timelines• Collecting, quality review and submitting documents to the TMF• Support planning and logistics for meetings• Generate, finalize and distribute study team agendas and minutes

Levallois Perret France

Set up and Maintain all project documentation files, records and application FilesPrepare and distribute status, tracking and project finance reportsPrepare presentation materials for meeting and project Summary dataTake and Record minutes, notes and actions at assigned meetings, distribute and follow up accordinglyEnsure that work is conducted in compliance with standard processesProvide general administration support to the Project Management team and support staff as neededOrganize internal and external meetingsServe as back up contact for internal project team as designated by Project Manager.

Education record

Master Coach

Marketing And Communication

Associate'S Degree, Marketing/Marketing Management, General