– Act as a primary contact with client for data management activities and for all related communication;
– Participate in review of clinical research documents (e.g. Protocols, CRFs (Case Report Forms), etc.);
– Support clinical data programmer in database programming and setup activities;
– Develop and maintain Data Management Plans (DMP) in accordance with design and requirements;
– Design CRF /eCRF (electronic CRFs) in accordance with the study protocol;
– Annotate CRF/eCRF in accordance with SDTM (Study Data Tabulation Model) standards;
– Generate CRF/eCRF completion guidelines;
– Develop Data Validation Plan (DVP): edit checks/rules, query logic and data validations;
– Perform User Acceptance Testing (UAT), testing of edit checks, data entry testing and raw data review;
– Develop manual checks: perform manual review of clinical listings throughout the study;
– Perform discrepancy management and resolution of queries within study timelines;
– Define electronic data transfer specifications and liaison with contract laboratories and other providers of electronic data to coordinate the receipt, ensuring that it is complete, consistent, in the required format and received in a timely manner (in order the project timelines are met);
– Perform Serious Adverse Event and non-CRF data reconciliation (such as Central Lab, Electrocardiogram, Imaging data);
– Record all the updates to the database in the corresponding documents (annotation specifications, DMP and DVP), keep the versioning of those documents;
– Ensure quality of clinical data within EDC (electronic data capture) prior to database Lock/Freeze;
– Ensure the data management activities are in consistency with the project team timelines;
– Generate project status reports and provide them to the corresponding project manager;
– Lead the set-up and maintenance of Trial Master File sections for data management activities;
– Utilize available systems and processes for coding medical terms and medications (with WHO Drug and MedDRA coding dictionaries);
– Participate in internal, client and investigator meetings;
– Work collaboratively with the Database Designers, SAS Programmers, Statisticians and Project Managers;
– Provide project specific EDC/process training to CRAs and site staff;
– Contribute to the training and development of new data management staff;
– Maintain compliance with all policies and procedures of the Company;
– Perform other job-related duties as assigned by the Chief Scientific Officer (CSO).
– University degree in Data Science, Data Management, Computer Sciences, Economics or another field. PhD degree is preferred;
– At least five years of experience in data management;
– Knowledge of pharmaceutical development process, clinical research, clinical data management and clinical information systems is required;
– Understanding of clinical regulatory processes, including those of US FDA (Food and Drug Administration) and EMA (European Medicines Agency);
– GCP (Good Clinical Practice) certificate is preferred;
– Excellent knowledge of English language;
– Excellent interpersonal and communication skills;
– Ability to work both as part of a team or independently;
– Ability to effectively interpret supervisor’s directions and communicate progress and problems in a timely manner;
– Ability to work under pressure and tight timelines.
REMUNERATION/ SALARY: Highly competitive, commensurate with experience.
APPLICATION PROCEDURES: Interested candidates are welcome to submit a CV for the job they are applying for. The above information should be sent to: email@example.com and mentioning the applicant’s email address and the title of the position “Senior Data Manager” in the subject line of the email.
ClinStatDevice is a US-based healthcare technology company delivering end-to-end clinical study support, data solutions and innovative technology services. Over the past years, our solutions and services have been transforming drug development and medical device research in many therapeutic areas and phases of clinical trials. To find out more, visit www.clinststdevice.com.