Sr. Executive / Executive Clinical Data Management
About the Role
Company Overview
Sun Pharmaceutical Industries Ltd is among the largest pharma companies in the world. It offers specialized services that include the manufacturing of generic and specialty drugs. The company is present in many therapeutic segments and operates in a wide range of countries. The company’s reputation stands out for its emphasis on quality, innovation, and regulatory compliance.
Job Summary
The Sr. Executive / Executive – Clinical Data Management role involves providing support and management for different clinical data management studies from setup to database lock. This would be done by ensuring that all data management activities are carried out in accordance with the company's standard operating procedures, ICH-GCP, and relevant regulations.
The selected individual will work with different teams to ensure accuracy and consistency of the data.
Key Responsibilities
This role includes monitoring all processes that are involved in data management for the assigned studies, starting from data management initiation until database lock. It will include participation in project meetings and providing a project update on data management status and issues.
This person will be involved in creating and reviewing data management documents such as the Data Management Plan, edit check specification, data transfer agreement, reconciliation plan, and coding guidance. All procedures must be in line with the study protocol and regulations.
This position will include clinical data review for accuracy and completeness, and consistency of information entered into the database. This person will create and resolve data queries in collaboration with sites and the project team. Data cleaning will be done by the person.
This person will work on training and giving system access to investigators, coordinators, CRAs, and site people on electronic data capture (EDC) systems.
It is also responsible for doing reconciliation of the data, which will include SAE, AE, external data files, and third-party vendor data, like central labs and IVR.
The incumbent will work with the medical reviewers/monitors for medical terminologies if necessary. They can also take part in investigator meetings and trainings.
They will also keep an eye on quality metrics and performance metrics and inform the stakeholders about the same. They will look for improvements in the process and implement best practices. At times, they can independently conduct data management for the assigned projects.
Qualification and Skill Requirement
Education: Bachelor’s degree in:
Life Sciences
Nursing
Computer Science, or
Related field
Experience: 3 years in clinical data management
Hands-on experience with the tools used for capturing clinical data is necessary.
Experience in understanding the guidelines of ICH-GCP and conducting clinical trials is compulsory. Hands-on experience in managing clinical studies around the world is an added advantage.
Analytical skills and the ability to work with minute details is necessary. One must have prior experience in reviewing and managing data queries.
Good communication and coordination skills are necessary in order to be able to communicate with cross-functional and external parties.
Microsoft Office Suite knowledge along with basic data handling capabilities is expected. Experience in medical coding will also prove to be an advantage.
Salary and Benefits
The organization provides a competitive salary based on industry norms. The salary for the position falls in the range of ₹8-10 LPA. Negotiations can take place depending upon experience and expertise.
Benefits to employees include exposure to international clinical studies, professional development opportunities, and learning experiences. Some additional benefits may include health insurance and a stable working environment in a reputable pharmaceutical company.
Role Importance and Career Growth
This job is very important for maintaining the high standards of quality, accuracy, and reliability in clinical trial data. Proper data management contributes directly to the regulatory submission and successful development of new drugs.
This is an excellent career opportunity that will help you develop and grow within the field of data management or other related positions like project management and clinical operations.
How To Apply
If this is the position you seek to apply for, you should apply through the following procedure:
Create your account in Jobslly.
Search for the position Sr. Executive / Executive – Clinical Data Management/ Sun Pharma.
Upload your updated resume.
Upload all the related certificates.
Complete the application form.
Ensure your resume highlights relevant education, attention to detail, and any experience in Clinical Data Management.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.