- Business development (business plan/model development, establishment of strategic partnerships, marketing plan development and implementation, meetings with clients and suppliers).- Quality Management System development and implementation (ISO 9001:2008).- Development of training programs and activities, for internal and external application.- Development of proposals and contracts, and respective budget estimates.- Project management and communication.- Case Report Forms, Patient Cards and Diaries, Electronic Data Capture forms development, according to the protocol. - Clinical Data Management activities.- Quality Control activities to assure quality of the deliverables and provided services.- Supervising clinical studies' implementation (from protocol design, to study report).- Implementing Advisory Boards and other clinical meetings.

- Participates in the review of clinical research documents (e.g. Study Protocols, CRF, Source Documents templates, Study Reports and Statistical Analysis).- Develops Data Management Plans (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.- Develops CRF, electronic and/or paper.- Designs/develops/tests database clinical study data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.- Develops/maintains all other Clinical Data Management related documentation (e.g. Data Validation Plan).- Understands key business issues that might impact Data Management deliverables.- Ensures appropriate data collection tools are in place for study start, and manages training in the use of data collection tools by assuring the creation of user guides.- Reviews study data and performs discrepancy management.- Handles database freeze/lock, as applicable, and ensures data within electronic data capture (eDC) is in quality to lock/unlock and freeze/unfreeze, as appropriate, for statistical review, interim review, and/or final database lock, included but not limited to: data reconciliation and/or coding.- Prepares the protocol deviations list.- Assists in Adverse Event/Serious Adverse Event reconciliation between the safety database and the clinical database, when applicable.- Maintains/tracks eDC user management and other clinical databases across clinical studies, including but not limited to compiling master user lists and activating/deactivating user accounts.- Contributes to SOP updates and author’s SOP as assigned by management.- Performs other duties as assigned by management.

- Ensure the proper operation and compliance with internal procedures, ICH GCP, regulatory requirements and GCDMP.- Develop and improves SOPs related to CDM.- Manage CDM related vendors.- Report projects plans and work progression to the management team.- Manage DM workload and meetings.- Account for timing and quality of data management deliverables/outputs/procedures.- Understand key business issues that might impact DM deliverables.- Review clinical study/trial protocol, before final version approval.- Manage users and roles in eDC tools.- Perform formal quality control before database release, freeze and lock.- Account for database freeze and lock related procedures.

- Reports trial/study status to the Clinical Data Manager Coordinator, as applicable.- Develops trial/study Data Management Plans.- Designs/develops/tests database and forms in the current software in use at Blueclinical.- Develops/maintains all Clinical Data Management related documentation (e.g. Data Validation Plan).- Understands key business issues that might impact Data Management deliverables.- Ensures appropriate data collection tools are in place for investigational site(s) for study start, and manage training related to clinical trial/study data collection tools.- Reviews study data and performs discrepancy management.- Handles database freeze/lock, as applicable.- Prepares the protocol deviations list.- Contributes to SOPs’ updates.- Performs other duties as assigned by management.

- Meetings with clients and suppliers.- Evaluation and development of proposals and contracts, and respective budget estimates.- Project management and communication with both clients and co-workers.- Management of human resources within the department.- Collaboration with the QA Department, in order to participate in the company’s audits (from the regulatory agencies or clients) and provide inputs for the quality management system continuous improvement.- Protocol and Case Report Forms review.- Review of the department's technical outputs/documentation (eg. Data Management Plans, Data Validation Plans, electronic databases, Data Management Reports).- Discrepancy management.Companies within the Group:Sep|2008 to Feb|2010 - KeyPoint, Scientific ConsultancyMar|2010 to May|2011 - DotPointMay|2011 to May|2012 - KeyPoint, Scientific Consultancy

- Project management and communication with both clients and co-workers.- Management of human resources within the projects.- Collaboration with the QA Department, in order to provide inputs for the quality management system continuous improvement.- Protocol and Case Report Forms review.- Elaboration of technical documentation (e.g. Data Management Plans, Data Validation Plans, Data Management Reports).- Review of databases before set to production – unit testing.- Discrepancy management.- Database freeze/lock.Companies within the Group:Sep|2008 to Feb|2010 - KeyPoint, Scientific ConsultancyMar|2010 to May|2011 - DotPointMay|2011 to May|2012 - KeyPoint, Scientific Consultancy

- Case Report Forms, Patient Cards and Diaries, Electronic Data Capture specific forms development, according the clinical trial protocol.- Interaction with the Project Manager and/or responsible CRA, Data Management and Biostatistics, Client, CRF Printing Vendor and Information Technologies Analyst and Developer.- Printing vendor qualification/selection.

- Support the Quality Assurance Manager in the review/approval of Data Management specific documentation and/or procedures (applicable for all projects assigned to other Data Managers).- Interaction activities with Data Management Coordinator, Study CRA, Statistician, Quality Assurance and IT personnel.

- Study set-up activities.- Database design (in Eurotrials current CDMS or other available software) and Database Release.- Development of Data Management support documentation.- Data Handling and Discrepancy Management.- Database Closure Activities.- Management of Database Operators.- Development and maintenance of study data management files.- Development and implementation of training programs and activities for Database Operators and Data-Entry Operators. - Interaction with Data Management Coordinator, Data Management Quality Controllers, Study CRA, Central Laboratories, Client, Medical Reviewer.

- Elaboration of annotated Case Report Forms.- Database forms design according to study Case Report Forms.- Development of documentation tracking lists.- Assist the Data Manager in data cleaning/validation procedures.- Assist the Data Manager in Discrepancy Management by correcting data after discrepancy resolution (in paper-based studies).- Data quality control procedures.- Development and implementation of training programs for Data-Entry Operators.- Interaction with Data Manager, Database Operators and Data-Entry Operators.

- Elaboration of annotated Case Report Forms.- Database forms design according to study Case Report Forms.- Data entry according to study Case Report Forms and data entry instructions.- Interaction with Data Manager and Data-Entry Operators.

- Data entry according to study Case Report Forms and data entry instructions.- Interaction with study Data Manager.