Clinical Data Associate sökes till TFS AB

A CDA is part of the Biometrics Unit and works operationally in preparing, conducting and completing Clinical Data Management tasks during the study process, according to company policies, Standard Operating Procedures (SOPs) and regulatory requirements. The main responsibilities of the CDA will include: .Create Case Report Forms (CRF) from scratch, from a draft or final protocol using FrameMaker CRF and query handling .Work with the Biometrics Unit in assisting with the Clinical Data Management tasks according to GCP, company policies and SOP's .Write and finalise Data Entry Instructions .Validate data entry applications .Perform data entry, proofreading and editing .Code (Adverse Events, concomitant Medications and Medical History) .Perform quality checks .Assist during the Clean File procedure .Correspond with clients regarding Clinical Data Management tasks..CRF-handling .Work with other members in the organisation to share knowledge, experience and best practices Additional responsibilities may include: .Participate in development and implementation of CDM related SOPs and process .Co-ordinating and instructing the Clinical Trial Supply Unit during production and printing of Clinical Study Material Other requirements/qualifications: .Suitable level of education .Good knowledge of spoken and written English .Good organisational skills .A service-minded approach to your work .Good interpersonal skills and teamwork .Ability to maintain effective and professional communication .Ability to prioritise and handle several tasks simultaneously .Experience with IT aids and working with PCs For more information about principal duties for a CDA, see our homepage www.trialformsupport.com We are looking forward to receiving your application with included CV and a personal letter.