Job Description :
Key Accountabilities
- Assume the ability to meet the requirements of a CDA with a high degree of proficiency and autonomy
- Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects
- Train team members on selected tasks
- Prepare Data Cleaning Specification
- Review the Data Validation Specification prepared by the Technical Analyst in GTS
- Develop or provide input to project specific guidelines, e.g. SAE handling.
- Initiate the running of study specific programs
- Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
- Conduct in-house data review,
- Generate and close queries or apply self-evident corrections to the data according to the relevant guidelines
- Identify and report protocol violations
- Manual and Patient Profile review, issue queries
- Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
- Track and integrate queries
- Perform clinical coding if appropriate to role within the project team
- If required liaise with 3rd party vendors to clean electronic data
- Ensure all documents coded for submission to central files
- Lock site(s) within EDC system - remove user's data modification privileges
- Interact with site (via mail) as required
- Perform early and final database QC activities
- Update all relevant tracking system on an ongoing basis
- Inform responsible CDA Coordinator of work status regularly
- Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor
Skills
- Good computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, knowledge of MS-Office products such as Excel, Word
- Sound awareness of all relevant regulations, including GCP
- Ability to successfully work in a (virtual) team environment
- Client focused approach to work
- Effectively applies knowledge to provide advice or solutions based on expertise
- Offers support and constructive feedback to project team members
- Seeks opportunities to develop experience and knowledge
- Ability to organize and plan tasks
- Excellent interpersonal, verbal and written communication skills
- Must be able to work independently but seek guidance when necessary, escalating issues as required
- Sense of urgency in completing assigned tasks
- Meticulous attention to detail
- Effective time management in order to meet daily metrics or team objectives
- Shows commitment to and performs consistently high quality work
- Willing and able to travel as required local or international
Experience :-
- 6 to 8 years of Minimum Relevant Clinical Data Management Experience
- Minimum of Graduation in Life Sciences of equivalent experience
- Fluent in English
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