Website:
veramed.com
Job details:
We are hiring for Clinical Data Coordinator with minimum 3 years of experience in Clinical data management.
About Veramed:
Veramed is a biometrics-focused CRO, primarily specializing in Statistics and Statistical Programming. Recently, we have also started expanding into Data Management and are in the process of building dedicated data management teams across the UK, US, and India. The company was founded in 2012 by Matthew Jones, a Statistical Programmer, and Emma Jones, a Statistician. Over the past 13 years, Veramed has grown significantly and now has a global workforce of around 750-800+ employees. We have a strong international presence, with three offices in the UK, two offices in Ukraine, and teams located in Spain, Germany, France, and the United States. In India, we launched our operations in March 2024, and within just two years we have grown to 170 employees, including contractors. Currently, we have an office in Bangalore, and our second office in Hyderabad will be launching soon. One of our key strengths is our employee retention, with a strong retention rate of around 92–93% globally. This role offers an excellent opportunity to work alongside experienced professionals, contribute to meaningful clinical research projects, and further develop your technical and programming skills in a collaborative environment
Summary of the role:
The role of the Clinical Data Coordinator II is to provide data management support to the data management department across a range of projects, sponsors and therapeutic areas.
Key Responsibilities
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs. All work will be performed in full compliance with applicable legislation, regulations, company policies, procedures and training.
Technical
• Review of clinical protocols
• Create or review Case Report Forms for data collection and compare with the protocol to ensure consistency and to ensure all endpoints are captured
• Create or review Edit Check Specification document
• Support the preparation of UAT documentation and perform UAT of EDC and communication of findings
• Support the creation of study specific documents such as Data Management Plan, Data Review Plan, eCRF Completion Guidelines, etc.
• Create or review specifications for data review listings and / or customized reports to facilitate data cleaning
• Ongoing review of data entered in EDC to ensure the data is clean for analysis
• Issue queries to clinical monitors or investigational sites as appropriate Resolve standard queries
• Perform medical coding
• Work with external vendors on data transfer agreements / specifications
• Ensure external data is reconciled as required
• Track queries and data cleaning activities to ensure ongoing review of data entered is completed and data is fit for analysis.
• Maintain study master file documents and any other documents that are required to be audit ready
• Work in accordance with internal (or sponsor, where applicable) SOPs and procedures
• Participate in internal sponsor audits and RFIs as needed Project Management
• Proactive identification and preparation of scope changes
• Ensure key project milestones are delivered on time with the highest quality
• Maintain timelines and communicate risks to the study teams
• Attend team conference calls if required from a data management perspective, provides metrics updates and is responsible for the DM timelines
• Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality
• Assist the Senior Clinical Data Manager in day to day project management activities
General
• Operate as an active member of the Data Management Operational Management Team
• Support the Veramed Data Management Leadership Team for specific business unit(s) by helping to define process improvements
• Participate internal and client study team meetings effectively
• Build effective collaborative working relationships with internal and sponsor team members
• Seek opportunities to develop innovative ideas and sharing when appropriate
• Contribute to development of internal training materials
• Contribute to internal process improvement initiatives
Minimum Qualification Requirements
• BSc or MSc in numerical discipline (or relevant equivalent industry experience).
• At least 3 years of data management experience
Other Information/Additional Requirements
• Understanding of clinical drug development process, relevant disease areas, endpoints, and different study designs
• Awareness of industry and project standards & ICH guidelines
• Excellent verbal and written communication skills
• Interpersonal/teamwork skills for effective interactions
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Demonstrated problem solving ability and attention to detail
• Project leadership experience
Ability to make informed and appropriate decisions
Click on Apply to know more.
