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18 Novotech Jobs
Senior Clinical Data Associate
Novotech
posted 5d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
The Senior Clinical Coding Specialist (SCCS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the Clinical Coding team ensuring that team members deliver in accordance with SOPs, best practices, and agreed timelines.
Work independently as lead clinical coder on multiple projects, providing medical coding of medical verbatim terms collected in clinical studies.
Conduct review of coded medical verbatim terms and decide whether an assigned dictionary code is correct or not and, if not, advise as to the correct code.
ensuring consistency with clinical coding conventions associated with each of the dictionaries, and study-specific conventions, if applicable.
ensuring consistency with clinical coding conventions associated with each of the dictionaries, and study-specific conventions, if applicable.
Generate data queries where applicable to resolve coding discrepancies including queries to clinical sites.
Gather study coding requirements.
Advise study team on scope of coding activities.
Undertake verification of dictionary licenses.
Advise study team on scope of coding activities.
Undertake verification of dictionary licenses.
Assist the clinical coder in defining and setting up synonym lists in the coding software applications in order to ensure efficiency and coding consistency across the life cycle of a clinical study.
Maintain coding documentation within project files as appropriate.
Generate and review status reports and metrics as appropriate.
Represent Clinical Coding group at internal / external meetings as appropriate
Represent Clinical Coding group at internal / external meetings as appropriate
Configuration and setup of coding applications and modules.
Assist with assessment and implementation of new coding technologies.
Provide troubleshooting expertise for coding applications and modules.
Assist with assessment and implementation of new coding technologies.
Provide troubleshooting expertise for coding applications and modules.
Take a lead role in the development of best practices, process improvement, quality control and governance related to all coding matters,
Provide Subject Matter Expertise on all coding related activities including, Medical dictionary policies, versioning and up-versioning, coding technologies and coding conventions.
Act as single point of contact for all dictionary licensing matters for both internal staff and for the dictionary providers including ensuring Novotech s licenses are up to date and financially consistent with the legal clauses of the license agreements,
Maintain up-to-date knowledge of dictionary versions.
Prepare coding convention plans as required for individual studies.
Project manage all coding activities across all study phases ensuring timely delivery of quality coding outputs.
Proactive identification of coding issues and timely resolution.
Provide training and mentoring to new team members for all coding related activities.
Novotech is proud to offer a great workplace.
We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them.
We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.
We look forward to contacting you regarding your application.
We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them.
We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.
We look forward to contacting you regarding your application.
Minimum Qualifications & Experience
Graduate in information science or life science related field, or similar.
More than four years experience in a Senior Clinical Data Manager/Clinical Data Programmer /Laboratory Data Specialist role in a pharmaceutical company, CRO or EDC software provider.
More than four years experience in a Senior Clinical Data Manager/Clinical Data Programmer /Laboratory Data Specialist role in a pharmaceutical company, CRO or EDC software provider.
Responsibilities
The Senior External Data Specialist (SEDS) is responsible for providing technical, procedural (SOPs) and planning leadership across multiple projects assigned to the external data group team members ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team.
Scope external study data requirements and effort for projects.
Project manage all external data related activities across multiple projects.
Provide expert advice on the transfer and expected formats of data transfer files.
Provide technological expertise and guidance on the best methods for handling laboratory data and other external data.
Create and maintain data transfer agreements.
Maintain study documentation within project files as appropriate.
Maintain study documentation within project files as appropriate.
Act as primary contact and study representative to third party data providers.
Effectively communicate transfer requirements and project timelines to various stakeholders.
Identify and communicate project risks.
Effectively communicate transfer requirements and project timelines to various stakeholders.
Identify and communicate project risks.
Ensure data integrity is maintained by implementing appropriate data controls for masked data.
Ensure delivery of timely data transfers and undertake quality reviews and testing activities.
Conduct external data reconciliation using available technologies and processes.
Raise queries to external data providers and track queries to successful resolution.
Provide listings to medical review team.
Assess and implement new data review and analysis processes and technologies.
Take a lead role in the development of best practices, process improvement, quality control and governance related to all external data matters.
Provide training and mentoring to team members in SOPs, software applications, and best practices.
Attributes and Skills
Expert domain knowledge and experience within clinical research and drug development.
Advanced knowledge in >1 EDC systems and laboratory processes.
Experience mentoring and training others.
Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities.
Excellent analytical, communication and problem-solving skills.
Advanced knowledge in >1 EDC systems and laboratory processes.
Experience mentoring and training others.
Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities.
Excellent analytical, communication and problem-solving skills.
Employment Type: Full Time, Permanent
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What people at Novotech are saying
Rating based on 2 Senior Clinical Data Associate
reviews
Anonymous · Other
in Bangalore / Bengaluru
Likes
Encourage new employee to gain skillsets
- Salary - Good
+5 more
Dislikes
Some times adhoc work request at the end of the day
Senior Clinical Data Associate salary at Novotech
reported by
6
employees
₹6.2
L/yr - ₹11
L/yr
15%
less
than the average Senior Clinical Data Associate Salary in India
View more details
What Novotech employees are saying about work life
based on 62 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novotech Benefits
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