Basel, Basel, Switzerland
My education and the internships/jobs I have completed allowed me to acquire a strong experience in: • Teamworking • Developing depth knowledge of FDA and ICH GCP requirements • Developing strong organisational abilities including negotiation ability • Developing eCRF specifications and edit check specifications, according to protocol and approved standards, and participating in user acceptance testing • Developing and maintaining project-specific Data Management plan throughout the life-cycle of the study I'm well speaking English, French and German. I like teamwork, and innovation. I'm curious and patient.
Led startup, conduct and close-out of several global clinical trials of Ph I to III; most recently managed high priority registration study (500+ pts, 30+ countries, 150+ sites) Led the operational risk management, being a force of proposal and ensuring proper documentation Led database lock activities from TM perspective, in collaboration with local/ global team. Led Clinical Study Report activities (CSR shell, body, narratives, and appendices) in collaboration with various stakeholders. Led inspection preparation activities Ensure audit readiness of Trial Master File (TMF) documentation. Develop specific sections of the protocol and related documents in accordance with SOPs Contribute to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines (eCCGs), data review reports, clinical study reports and trial statistical analysis plan in collaboration with the trial data manager, trial statistician, statistical programmer, and clinical development representative. Manage study level recruitment and planning of patient recruitment Support forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholder. Contribute to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); manage interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards. Manage interactions with relevant line functions including data management, drug supply management, clinical development, and Country Organizations. Support the GTD with the development, management and tracking of the trial level life cycle budget, forecast and annual cost targets. Ensure proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
Study team Lead experience on complex studies: - Management of DM metrics (number of queries in all status, number of missing pages, number of missing visits, number of missing signatures) - Plan goal priorities and review of timelines in accordance to the customer and all stakeholders. - Management of quality procedures : get sure all team members has been well trained and signed a training transcript, get the insurance that the Standard Operating Procedures are available - Ensure data system compliance by following guidelines of international regulatory authorities and internal policies - Participation to process review and amelioration : creation of tips and of new tools - Financial reports review every month, and management of workscope - Management of communication with the customer and with people included in the project (CTH, TDM, Statistician, CMM, safety) by having Data review meetings and by using emails. Clinical data management activities within clinical projects, including: - Train and follow up of offshore staff (India, China, South-Africa): training on operational activities as query generation and resolution. Management of the team work quality - Creation of eCRF and checks Data validation activities (as a Validation Team Lead): - Validation of eCRFs by testing if all pages are correct and in the right order - Validation of checks by creating test cases and by the creation of test patients - Edition of queries, implementation of correction manually or automatically - Ensures by making control quality tests if the quality data collection techniques are established - Reconciliation of various data by comparison between the third vendor data and by data present in the database (SAE reconciliation, third vendor reconciliation as, Imaging reconciliation) : management of external providers - Support to CRAs by helping them using the database and by asking them completing missing data and by training them in order they can help PI to answer queries
Discover of various aspects of clinical research by managing a Phase I study with few patients: - Clinical Research Associate Tasks : New sites monitoring included in the study, train of the staff, explanation of the goals and of the study needs. - Clinical Data Manager tasks : Organization and follow-up of clinical trials, creation of observation books, creation of databases, edition of queries, implementation of correction, creation and validation of checks, internal and on-site data quality control. - Activities of pharmacovigilancy: Collection, follow-up and statement of the SAE.
Overview of Clinical Data Manager position, Work under pressure, with efficiency and tight deadlines.