Basel, Basel, Switzerland
As a Global Validation Manager, I bring extensive experience in project management within the pharmaceutical and medical/dental devices industries, with a specific focus on clinical trials phases I-IV and dental sectors. I have a proven track record of effectively managing and facilitating communication between external stakeholders, sponsors, vendors, and internal teams. My role involves addressing challenges, monitoring productivity, establishing KPIs, and ensuring high quality deliverables that comply with standard operating procedures and regulations (e.g. HIPAA, FDA, GDPR). I am skilled in preparing and formatting datasets to achieve optimal outcomes. Passionate about talent development, I am committed to both training others and continuing my own professional growth. I am eager to broaden my expertise by integrating my healthcare background with business focused strategies. Skills: Project Management, Motivated, Hardwork, Leadership, Communication, Organized, Teamwork, Responsible and eager to learn new things. Different experiences in life can build a strong mind, but only if you have the strength to overcome them.
Lead all Clinical Data Management activities related to the delivery of subject data for clinical trials. Work directly with customers to reach a complete understanding of their needs, contractual timelines and deliverables. Working across departments to exceed customer expectations and provide ongoing, quality communications and deliverables for projects. Applying the protocol to daily data management tasks, delivering project specific training to clinical data associates, and coordination of data cleaning tasks, ensuring quality standards are maintained and delivered within agreed timelines. Involved in creation of database specifications, build and user acceptance testing during the development of database and edit checks. Also involved in the creation of data management documentation, leading team and client meetings and providing mitigations for risk management.
Accountable for all protocol level start-up, in-life and database lock tasks and activities performed by DM team. Interact and communicate with costumers and stakeholders both internal and external, as well as our company when needed. Accountable within designing, creating, validating, reviewing, approving and maintaining data management tool specifications, including but not limited to: CRFs, schedule or time and events, entry guidelines, edit checks, data management plan, in-life reports and encoding. Coordinate the execution of user acceptance testing of data management tools. Provide inputs in to the preparation of the investigators meetings materials, and makes available for questions for them. May present data management instruction at investigator meetings based on business need and management decision. Participate in relevant operational meetings to identify and incorporate global operational issues into the study design. Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects. Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level and project management level. Support and execute any role or task in the team when needed.
Participate in relevant operational meetings to identify and incorporate global operational issues into the study design along with the lead clinical data manager. Execute and trigger communications and escalations at the protocol level within department, and external stakeholders. Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level. Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes.
Receives the study related paper documents from sites or other functional areas, and transfers to data entered for processing. Performs Sponsor Data Entry as applicable per data management plans following entry guidelines. Execute data validation activities in accordance with relevant Standard Operating Procedures. Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution. Responsible for the execution of user acceptance testing of data management tools under the guidance of the Senior Clinical Data Manager/Lead Clinical Data Manager. Escalates overdue items, including but not limited to outstanding questions and missing visits. Assists the Senior/Lead Clinical Data Manager with data management activities to resolve all identified data issues prior to study database lock.
2nd year Clinical supervisor and professor at Dentistry School at USM