Associate Clinical Data Recorder Amsterdam • Gi Group

Associate Clinical Data Recorder

Serve in support-level capacity to perform assigned tasks on a Clinical Data Management team to provide efficient, quality data management services that meet customer needs.; Perform Data Management and/or coding activities under supervision.

Essential Functions

• Serve independently as a Clinical Data Coder (Coder) or take a lead role (e.g. Lead Coder) in a specific area or process on one or more protocols with guidance.

• Perform Medical Coding using MedDRA, WHO Drug and/or other relevant dictionaries.

• Validates coding system set up and coding reports

• Conduct data review.

• Write and resolve data clarifications.

• May perform Serious Adverse Event (SAE) reconciliation activities with guidance.

• May develop and test databases and edit specifications.

• Understand and comply with core operating procedures and work instructions

• May serve as a back-up for a DOC.

• Perform other duties as directed by the study team or Manager, or meet objectives as assigned.

• Develop and maintain good communication and working relationship with the team.

Qualifications

• Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent

• Up to 2 years relevant experience or equivalent combination of education, training and experience.

• Good knowledge of medical terminologies, pharmacology, anatomy and physiology.

• Good knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD etc.).

• Basic knowledge of applicable research and regulatory requirements.

• i.e., ICH GCP and relevant local laws, regulations and guidelines.

• Basic understanding of database technologies and drug development process and its relevance to data management.

• Excellent written and oral communication skills in English language, organizational and computer skills.

• Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems.

• Ability to establish and maintain effective working relationships with co-workers, managers and clients."