Job Description

Job Title: Clinical Data Associate II (CDA II) (Cmed CRS) At Interview Stage

Reports To: Team Manager or Principal Clinical Data Manager

Department: Data Management Operations (DMO)

Core Responsibilities

Provide professional administration and data management of clinical trial data. Identify and request clarification of inconsistent and incomplete data. Ensure resolution to errors in order that databases can be declared clean and locked according to ICH GCP standards.

Principal Accountabilities

• Review clinical trial documentation e.g. protocol, validation document and Case Record Forms (CRFs) and provide input as appropriate. Contribute to the design and user acceptance testing (UAT) of new clinical trial databases and validation programming


• Maintain accurate documentation and filing systems to ensure safe and secure storage of data


• Ensure ongoing data entry from CRFs or other sources into the clinical trial database as documented in the Data Management Plan (DMP), within agreed timeframes and to a high standard of accuracy


• Perform relevant Quality Control (QC) checks on the entered data to ensure accuracy.  Apply Self Evident Data Corrections (SEDCs) as appropriate, and as documented in the DMP


• At the discretion of the Trial Data Manager, perform “first line validation” – generate and send data queries and initiate their resolution via the Sponsors preferred approach. Perform data edits on return of the resolution as appropriate, and perform QC checks of other team members data query resolutions


• Identify and resolve errors or inconsistencies raised via manual review and listing review


• Maintain an accurate status of data and query processing, e.g. data entered, cleaned and (QC’d). Be able to provide status information on allocated data to the Trial Data Manager


• Ensure relevant Sponsor and / or Cmed CRS Working Practices or Standard Operating Procedures are adhered to


• Communicate effectively and as appropriate with the Sponsor e.g. via e-mail with Study Monitors in order to manage allocated data


• Assist and act as deputy for Clinical Data Manager


• Assist in coaching of new or inexperienced Clinical Data Associates I and II (CDAI, CDAII)


• Provide input to improving the effectiveness of the organisation such as developing new processes, systems and Customer relations


• Ensure timely and accurate entry of relevant study information and time recording occurs in the Management Information System (MIS)


• Other tasks as assigned by Team Manager

Essential Work Experience And Qualifications

• Preferably degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience


• Or 1 years experience in drug development ideally in the discipline of data management


• Foreign language skills would be advantageous.

Attributes

• Good organisational skills


• Good interpersonal and communication skills, and the ability to operate effectively in a team environment


• Work calmly under pressure and meet deadlines


• Professional, positive, dynamic and driven


• A basic understanding of medical terminology, clinical trial methodology and ICH/GCP and the drug development process


• An investigative and meticulous approach to all activities and tasks


• Transparent approach, clear and precise


• Team player


• The ability to work effectively and efficiently with internal partners within Cmed


• Eagerness to learn and develop new skills