Anna Lindsjö Email and Phone Number

I contribute to the definition of strategies for the data capture and analysis process. I am involved in development, implementation and maintenance of our processes and standards to ensure provision of data management expertise for our clinical development.I act as mentor and provide data management consultancy and advice when relevant.In development projects I interact with colleagues and collaborators within and across departments in order to understand their needs and to provide the needed data management specialist input. I have strong communication skills and support an open and honest dialogue.I am responsible for performing oversight of outsourced studies and act as sponsor CDM.

Responsible for the coordination of the data management work and staff management within the Clinical Data Management section in Copenhagen and Paris. Direct line manager for ten Clinical Data Managers and consultants. I utilised my leadership skills to combine my management tasks with the role as being a mentor/coach for the employees and their personal- and work related development. This added value since we were able to retain our employees despite challenges with organisational changes and a move to a more flexible work role within data management.I was responsible for setting the direction for the section in agreement with the Head of Department and overall divisional goals which required me to define SMART goals, to be able to evaluate progress and achievement.When carrying our performance reviews and status meetings I created a positive and safe platform for an open and honest feedback culture. I worked together with the employees to define their development plans and helped identifying the need of training and included both work related and personal training. I have used situational based leadership to challenge and support the employees where relevant.Since I use a direct approach in regards to communication, I facilitated to make the European section more open and this improved the collaboration within the department and made the employees more visible and empowered in the study teams. I acted as chair for the Data management advisory group to ensure adherence to standards, processes and to support best practice. I contributed to having fewer deviations to our standards and to increase our knowledge across studies. I have been available for support to the data management department including sites in Singapore and US which taught me to focus on culture differences and communication styles.

Managed all data management activities from study kick-off meeting to archiving in conjunction with clinical trials. This included all aspects of study set-up, user training, data validation and release of a database for statistical analysis as well as documentation and archiving of performed tasks. This implied communication and collaboration with a wide variety of team members worldwide and adherence to current SOPs and regulatory guidelines.Acted as contributor and reviewer of steering documents within Biometrics division and part of advisory group for data management processes and best practice within drug development.Responsible for a cross-functional process improvement project which resulted in a new workflow in our studies and development my understanding of the drug development process and stakeholder management even further.

Responsible for managing all data management activities including guidance of data management staff. Contributed to the development of the processes in relation to data management SOPs and acted as mentor within clinical data management department which resulted in a promotion of a Data Assistant to Clinical Data Manager. Assisted in proposal work which secured the data management costs to be more accurate.

Responsible for managing all data management activities including guidance of data management staff. Contributed to the development of the processes in relation to data management SOPs and acted as mentor within clinical data management department.Worked close together with the Head of Department to secure resource planning in the projects.Acted as deputy process representative in Clinical Data Management coordination group (one year) which included training for data managers and other roles in the company.

Acted as direct line manager for one of four sections within the Clinical Data Management department.Guidance of data management staff in daily activities and responsible for their development by performing appraisals, participated in budget process and resource allocation to the projects.Participated in the work with the Clinical Data Management SOPs within the Company´s global quality handbook.Assisted in proposal work, participated in the recruitment process as well as represented the data management department at conferences and client meetings.

Data Manager, Clinical Data Care in Lund AB, SwedenResponsible for the database design and validation, programming and design of listings and files for statistical work.Performed CRF logging and sorting, Data entry and verification, validation and editing of data. As Data Manager I participated in clean file procedure and prepared the database for lock. The role also included guidance of data management staff within the project.

Responsible for the database design and validation, programming and design of listings and files for statistical work.Performed CRF logging and sorting, data entry and verification, validation and editing of data. As Data Manager I participated in clean file procedure and prepared the database for lock. The role also included guidance of data management staff within the project.

Performed CRF logging and sorting, data entry and verification. Validation and editing of data. Programming of data entry screens and programs for printing.