Quanticate

Clinical Data Coordinator I

Job Locations IN-Bangalore
Posted Date 2 weeks ago(8/3/2022 1:51 AM)
ID
2022-1871
# of Openings
1
Category
Data Management

Overview

            To action all tasks relating to Clinical Data Management from the start to the finish of a study.

            To support Project Manager in studies across DM functions.

Responsibilities

Core Accountabilities:

Activities required of a Clinical Data Coordinator I (however not restricted to) are as below:

            To assist in the testing of databases prior to activation.

            To assist in the preparation of study specific documentation as appropriate.

            To assist with the processing of clinical data for projects.

            To critically review CRFs as specified in the Data Management Plan and to query any errors or omissions with either the study sponsor or the investigator as required.

            To track and resolve Data Clarification Forms in the study specific Database.

            To resolve Self-Evident Queries/Allowable Changes in the study specific Database.

            To perform the Quality Control of Data Entry and CRF/database as appropriate.

            To prepare any documentation for return to client/internal archiving at study completion as requested.

            To be aware of and to work to the standards appropriate to the study (CRO or customer).

            To advise on possible improvements to procedures and standards.

            To perform medical coding activities on projects, if assigned.

            To perform other reasonable tasks as requested by management.

 

Role-Specific Duties:

            Assist Leadership team in ensuring launch, delivery, and completion of all Data Management procedures according to contractual agreement and relevant SOPs, guidelines and regulations.

            Ensure consistency of process and quality across projects.

            To undertake other ad hoc tasks as required.

 

Freedom to Act:

            Assist in Monitoring project progress to the customer and project team, including use of project status reports, and tracking tools/metrics.

Qualifications

Education:

            Qualified to an appropriate standard, preferably to degree level in a life sciences subject

 

Skills, Knowledge, and Experience:

            PC skills, including some knowledge of Excel and Word.

            Extensive knowledge of at least 1 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform.

            Excellent organizational skills and analytical skills and attention to detail.

            Good communication skills (oral and written) and good analytical skills.

            Basic knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

            Ability to manage competing priorities in a changeable environment.

            Ability to inspire effective teamwork and motivate staff.

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