Senior Clinical Data Associate

Precision Medicine Group; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Precision Medicine Group in Bengaluru is looking for a Senior Clinical Data Associate to manage clinical trial data. Responsibilities include supporting data management processes, ensuring quality control, and collaborating with stakeholders. Candidates should have over 5 years of experience and proficiency in Microsoft Office, with a strong understanding of drug development practices.

The role requires excellent organizational skills, effective communication in English, and the ability to work autonomously and as part of a team.

Qualifications

• 5+ years of experience in clinical data management.
• Demonstrated knowledge of ICH-GCP and regulatory guidance.
• Ability to handle various clinical research tasks.

Responsibilities

• Support Lead DM and contribute to clinical data management.
• Perform database development and quality control.
• Communicate with study sponsors and project teams.

Skills

Proficiency in Microsoft Office

Excellent organizational skills

Excellent communication skills

Basic knowledge of drug development

Education

Bachelor's degree or equivalent

Tools

Microsoft Word

Microsoft Excel

SAS programming

Job description

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.

Responsibilities

• 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, and 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

• 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

• 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

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.