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2.0 - 6.0 years
0 Lacs
karnataka
On-site
You will be working as a Clinical Data Coder 1 with a focus on MedDRA and WHODD coding. With 2-5 years of work experience, the role is based in Bangalore and requires office-based work. Your key skills will include expertise in MedDRA, WHODD, clinical data coding, and clinical coding. As a Clinical Data Coder, you will provide essential data management support to the Data Management team to meet sponsor and company requirements effectively. You will be responsible for Clinical Data Management and/or Coding activities, potentially leading as a Lead Coder or Data Operations Coordinator for specific tasks on mega trials. Your main responsibilities will include managing coding activities and projects throughout the study life-cycle with minimal guidance, validating coding applications and reports, conducting data reviews, resolving data clarifications, and ensuring coding project timelines are met. Additionally, you will be involved in Serious Adverse Event (SAE) reconciliation activities and may act as a backup for Lead Coders or Data Team Leads. Your role will also involve performing quality control procedures, assisting in implementing new technology, handling audit requirements for studies, and ensuring compliance with operating procedures and work instructions. Effective communication and collaboration with the team will be essential, along with maintaining strong working relationships. To qualify for this role, you should have a degree in Pharmacy, Dental, Medical, Nursing, Life Sciences, or a related field. You must possess excellent knowledge of medical terminologies, pharmacology, anatomy, and physiology, along with in-depth familiarity with medical dictionaries such as MedDRA and WHODD. Understanding the Data Management process from study start-up to database lock will be crucial for success in this position.,
Posted 1 week ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a Clinical Data Coder 1 specializing in MedDRA and WHODD, with 2-5 years of work experience, your primary responsibility will be to provide comprehensive data management expertise to the Data Management (DM) team for meeting sponsor and company needs. You will be involved in performing Clinical Data Management and/or Coding activities, taking on leadership roles such as Lead Coder or Data Operations Coordinator (DOC) for specific CDM tasks, or leading coding tasks on mega trials. In this role, you will independently manage coding activities and projects throughout the full study life-cycle, ensuring high quality and timely delivery with minimal guidance. Your responsibilities will include validating and testing coding applications and reports, conducting data review, resolving data clarifications, and managing coding project timelines under the guidance of the DOC or Data Team Lead (DTL). Additionally, you will be involved in Serious Adverse Event (SAE) reconciliation activities, performing quality control procedures, and assisting in the implementation of new technology related to coding and data management. You will also be expected to handle audit requirements for studies, maintain compliance with core operating procedures and work instructions, and collaborate effectively with the study team. To excel in this role, you should hold a qualification in Pharmacy, dental, medical, nursing, life sciences, or a related field, with excellent knowledge of medical terminologies, pharmacology, anatomy, and physiology. You should possess in-depth knowledge of medical dictionaries such as MedDRA and WHODD, and have a solid understanding of the Data Management process from study start-up to database lock. Your ability to bring coding and project-related solutions to the DM team, maintain good communication within the team, and adapt to changing requirements will be crucial for success in this position. Your dedication to meeting objectives as assigned, along with your attention to detail and commitment to quality, will contribute to the overall success of the data management processes within the organization.,
Posted 3 weeks ago
2.0 - 5.0 years
3 - 8 Lacs
Thane, Bengaluru
Hybrid
Job Title / Primary Skill: Clinical data coder Years of Experience: 2-5 Years Job Location: Bangalore/Thane Must Have Skills: Clinical coding, MedDRA, WHODD, Clinical data management Good To Have Skills: Rave, Job Description Provide comprehensive data management expertise (defined as efficient and quality data management products) to Data Management (DM) team to meet sponsor and company needs. Perform Clinical Data Management and/or Coding activities, and may provide leadership either in the role of the Lead Coder or in a specific CDM task (e.g. Data Operations Coordinator (DOC) or lead a coding related task on a mega trial). In-depth knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD etc.). Understanding of the Data Management process from study start-up through to database lock. Essential Functions • Serve independently as a Clinical Data Coder and/or Lead Coder or DOC for one or more protocols. • Manage delivery of coding activities and/or stand alone coding projects through full study life-cycle (with minimal guidance). • Validates/tests the coding application and programming of coding reports • may also test coding related datasets, coding related edits or any coding related programming activities. • Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications. • Manage coding related project timelines with guidance from the DOC or Data Team Lead (DTL) or Manager. • Perform Serious Adverse Event (SAE) reconciliation activities. • May serve as a back-up for a Lead Coder, DOC or DTL. • Perform comprehensive quality control procedures, Assist in implementing new technology. • Independently bring coding and project related solutions to the DM team. • Handle audit requirements for respective studies including stand-alone coding projects as applicable. • Understand and comply with core operating procedures and work instructions. • Perform other duties as directed by the study team or Manager, or meet objectives as assigned • Develop and maintain good communication and working relationship with the team. Professional Attributes Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Educational Qualification: Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent
Posted 2 months ago
3.0 - 5.0 years
4 - 7 Lacs
vadodara, manjusar
Work from Office
Department - Clinical Roles and Responsibilities: End to End clinical data management and pertinent documentation for clinical studies and real-world data collection. Managing vendors for CDM Conducting User Acceptance Testing Provide guidance on training requirements in relation data management System and technical Skills Regulations and Standards 21CFR part 11, GDPR, ISO 27001, SDLC and ISO 62304, CDISC standards Databases & ORM: EDC databases - Clinion, OCRDC, Oracle one, Inform, Open clinica, etc. MS Access Tools: MS office, Power Automate, Power BI, MedDRA, WHODD, Rave, Clinion, Research Manager Understanding of the Medical Device industry
Posted Date not available
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