Data Compliance Specialist

Work Schedule

Environmental Conditions

Job Description

Provides compliance support to the clinical trial process by ensuring all study documentation and source data is captured accurately in eCRF, up to date and first time right. Performs quality reviews and answers any eCRF queries in a timely manner. Reviews accuracy of the Investigator Site Files (ISF) as well as performs quality compliance checks and answering any CRF queries in a timely manner

• Act as the primary point of contact for sponsors representative.

• Maintains ISF and study trackers as delegated and ensures that ICFs are correctly completed.

• Completes data capturing activities on one or more studies across multiple sites and regions.

• Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries.

• Verifies protocol visit windows are correct according to the protocol requirements and reports deviations.

• Assists monitors and sponsor representatives with query resolutions after monitoring visits.

• Interprets and adheres to company SOP and COP and assists with input during the review process.

• Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.

• Assists with drafting compliance reports.

• Assists with archiving procedures as needed.

• Liaises frequently with monitors and client representatives. Performs preparation of monitoring visit duties and clarifies any expectations relating to CRFs.

• Supports audit preparation and ensures audit readiness.

• Identifies and escalates common data errors and trends and may assist with CAPA and problem solving methods.

• 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 2+ years).

• Clinical Trials OR clinical experience is essential

• Experience of working under different pressures as you'll be managing various studies 

• Document management

• Strong communication

• Strong organisation and time management

• Work is performed in an office environment with exposure to electrical office equipment.

• Occasional drives to site locations with occasional travel both domestic and international.

• Frequently stationary for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Frequent mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.