An international contract research organisation is advertising a vacancy for a Clinical Document Associate (CDA) III. The company, which provides drug discovery, lifecycle management, and laboratory services, is seeking for a driven and talented individual to join their company in their office in Bulgaria. This is an exciting opportunity to work with a company that provides innovative ideas behind multiple pharmaceutical sectors.
- Performing all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.
- Supporting the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.
- Reviewing data listings for accuracy and consistency of data.
- Acting as point person and subject matter expert for specialized study-specific processes.
- Generating, tracking, and resolving data clarifications and queries and making changes to the clinical database as required.
- Contributing to the improvement of data management processes on a global level.
- Producing project-specific status reports for CDM management and/or clients on a regular basis.
- Providing training and work direction to junior staff as required.
- Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs, and client expectations.
Skills and Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years') or equivalent combination of education, training, & experience.
- Valid driver's license and passport.
- Knowledge of medical/clinical terminology.
- Understands project protocol and DVM.
- Proven ability in achieving applicable technical competencies per the DM competency grid.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Magenis at +44 203 854 1050 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.