Lysette

Senior Clinical Data Manager

Executing end to end data management activities pertaining to clinical trials, including data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.. Performing and executing Run and review of standard reports and Ensure the integrity of clinical data and that the study is conducted in compliance with protocol, applicable regulations and SOPs.. Performing query management, database lock preparation, in compliance with Merck Standard Operating Procedures (SOPs).. Participating in the activities of the final DBL such as Data validation Workbooks, DRP checker, review of MPRs reports, AGG reports, Vendor ́s and perform Germany sites PI eSignature.. Leading and supervising the planning, collection, validation and management of clinical trial data to ensure accuracy, completeness and compliance with regulatory standards.. Developing Data management plans, coordinating with cross-functional teams, managing data cleaning and query resolution, ensuring regulatory compliance, mentoring and training team members, risk management and issue resolution, and performing reporting and documentation.

Organize and direct the flow of patients between different levels of care, ensuring fluid communication between healthcare facilities.. Receive, process, and execute referral and counter-referral requests from users, either by telephone or through computer systems.. Follow up with referred patients, verifying that they receive the necessary care and that established deadlines are met.. Communicate with various healthcare services, both within and outside the institution, to ensure proper patient care.. Identify and resolve problems or bottlenecks in the referral and counter-referral process, seeking efficient solutions.. Maintain up-to-date information on the healthcare provider network and referral and counter-referral protocols.. Participate in the evaluation and continuous improvement of the referral and counter-referral system, analyzing data and providing feedback to the various stakeholders involved.

Manage, oversee, and optimize the operations of a laboratory, whether clinical, research, or other.. Staff management, project coordination, equipment maintenance, protocol implementation, and inventory and supply management.

Direct and coordinate activities related to the diagnosis and treatment of diseases of the blood, bone marrow, and lymphatic system.. Resource management, staff supervision, and the implementation of quality protocols and standards, ensuring efficiency and accuracy in the analysis and handling of blood samples.