Senior Clinical Data Associate

Project Farma (PF); Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Precision Medicine Group in Bengaluru is seeking a Senior Clinical Data Associate to provide data management support across the clinical trial lifecycle under supervision. You will assist in creating CRF specifications, build and validate databases, perform UAT, QA, and generate line listings and reports.

The role requires strong knowledge of ICH-GCP, CDISC standards, and proficiency with MS Office; experience with EDC, SAS programming and vendor coordination is preferred.

Qualifications

• Bachelors and/or related experience required.
• Excellent written and verbal English communication.
• Proficiency in Microsoft Office suite.
• Good organizational and data management skills.

Responsibilities

• Back-up data management support to Lead DM and team.
• Data entry for paper-CRF studies and QA checks.
• Develop CRF specs from study protocol and coordinate stakeholder feedback.
• Build/maintain clinical databases and perform UAT.
• Create documentation and maintain versioning of DM docs.
• Train staff on study CRF, EDC, and related items.
• Review data per Data Management Plan and generate reports.
• Coordinate SAE/AE reconciliation and liaise with vendors.
• Support SAS programming and quality checks of programs.
• Ensure timelines and data quality meet project deadlines.
• Occasional travel may be required.

Skills

ICH-GCP

SOPs/WIs

Communication

MS Office

EDC

SAS programming

Project coordination

Education

Bachelor's degree

Tools

SAS

EDC

CDISC standards

Job description

Job Description

Position Summary

The SeniorClinicalDataAssociateprovides datamanagement support and assistance in all aspects of the clinicaltrial datamanagement process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional datamanagement activities.

Essential functions of the job include but are not limited to

• Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner
• May perform dataentry for paper-CRF studies, as needed
• May perform quality control of dataentry
• May provide input into timelines. Ensure that clinicaldatamanagement deadlines are met with quality. May assess resource needs for assigned projects, as needed.
• Assist in developing CRF specifications from the clinicalstudy protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinicaldatabases
• Conduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clinicaldatabase.
• Assist in specifying requirements for all edit check types e.g., electronic, manual datareview, edit checks, etc.
• Responsible for creating, revising, appropriate versioning and maintaining datamanagement documentation.
• Train clinicalresearch personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinicaltrial dataaccording to the DataManagement Plan
• Perform line listing datareview based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Assist with coordinating SAE/AE reconciliation
• Assist with liaising with third-party vendors such as external dataand EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the DataManagement department
• Identify and troubleshoot operational problems, issues, obstacles, barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and ClinicalStudy Reports (CSRs), if required by the project
• May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to datamanagement and database management activities
• Trains and ensures that all datamanagement project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned.

Qualifications

Minimum Required

• 5+ years’ experience
• Bachelors and/or a combination of related experience

Other Required

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinicalresearch tasks.
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral.
• Basic knowledge of drug, device and/or biologic development and effective datamanagement practices.

Preferred

• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)
• Oncology and/or Orphan Drug therapeutic experience

Skills

Demonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatoryguidance, as well as the ability to implement and drive outcomes

Competencies

• Motivates project team members to meet timelines and project goals
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Resolves project related problems and prioritizes workload to meet deadlines with minimal support
• Exhibits a high degree of self-motivation, and can work and plan independently as well as in a team environment
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills

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