Senior Clinical Data Associate
Senior Clinical Data Associate
Precision Medicine Group
Job description
Looking to enter clinical data management and clinical research? Explore the Senior Clinical Data Associate role at Precision Medicine Group in Bangalore, Karnataka.
Company Description
Precision Medicine Group is a global life sciences organization focused on advancing drug development and commercialization. Its services cover areas including clinical development, biomarker-driven research, laboratory services, translational science, data and technology, and commercialization support. The company has a global team of 3,500 experts serving pharmaceutical and life sciences organizations.
Job Summary
The Senior Clinical Data Associate role is based in Bangalore and focuses on supporting clinical trial data management throughout the study lifecycle. The position works with Lead Data Managers, project teams, sponsors, vendors, and other stakeholders to maintain data quality and meet study timelines. Some of the responsibilities may include: Development and testing of clinical databases, supporting CRF definition, UAT, edit-check requirements, data review and querying, medical coding, reconciliation operations, reporting, documentation and team training. The work may also include providing SAS programming help, reviewing research materials and addressing operational difficulties impacting data management activities.
Primary Responsibilities
Act as a team member or back-up to the Lead Data Manager and help ensure continuation of assigned projects.
Contribute to the development of CRF requirements.
Help develop the clinical database and conduct database build UATs with controlled documentation.
Help define requirements for electronic, manual and other methods of data edit checks.
Create, revise, version and maintain clinical data management documents.
Train clinical research professionals on study specific CRFs, EDC systems and other project needs as needed.
Perform line-listing evaluations and prepare reports on patient- and study-level status and metrics.
Perform medical coding activities to ensure consistency and medically appropriate logic.
Support SAE and AE reconciliation operations
Liaise with external data and EDC vendors to support time frames and data related deliverables.
Support SAS development and Quality control of SAS programs for the Data Management department.
Review metrics, audit findings and comments from project stakeholders to identify and help resolve operational concerns.
Provide support in review of Protocols, Statistical Analysis Plans and Clinical Study Reports as needed.
Support the creation and upkeep of SOPs and process documents relating to data and database administration.
Ensure that members of the data management project team are provided with enough training.
Make periodic trips and perform other duties as allocated to the position.
Educational Qualification
Bachelor's degree or equivalent combination of education and experience.
Previous experience in a clinical, scientific or health care discipline is desirable.
Skills Needed
Good knowledge of ICH-GCP, relevant SOPs and regulatory guidelines
Familiarity with clinical data management procedures and medication, device and/or biologic development.
Proficient in Microsoft Word, Excel, PowerPoint and Outlook.
Knowledge of medical code dictionaries such as MedDRA and WHODrug is desirable.
Oncology and/or orphan drug therapeutic experience desired.
Good organizational and interpersonal skills.
Ability to handle several clinical research initiatives and prioritize tasks to meet deadlines.
Ability to troubleshoot and resolve project related difficulties with minimum supervision.
Ability to work independently and collaboratively within a project team.
Self motivation, professionalism and a desire for ongoing growth.
Ability to motivate team members and drive projects to schedules and objectives.
Salary Structure
The average salary of Senior Clinical Data Associate is ₹10 Lakhs to ₹13.5 Lakhs.
Career Development
Exposure to a wider range of areas such as clinical data administration, database activities, medical coding, regulatory standards, vendor coordination, study documentation, and team training. It can also allow experienced professionals to build on their technical and project-management skills.
How to Apply
Check out our employment portal for a Senior Clinical Data Associate.
Click on the listing for a detailed job description.
Enter your details and attach your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
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