Senior Clinical Data Associate New Bangalore, Karnataka, India

Precision Medicine Group; Bengaluru; On-site; INR 900,000 - 1,300,000; 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 CRF specifications, database builds, UAT, data QA, and documentation, while training staff on study-specific tools and processes.

Qualifications include 5+ years in data management, a Bachelor’s degree or related experience, and strong organizational and English communication skills.

Qualifications

• 5+ years’ experience in data management and clinical trials.
• Bachelor’s degree or related experience in a relevant field.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills.
• Professional use of English language; both written and oral.
• Basic knowledge of drug, device and/or biologic development and data management practices.

Responsibilities

• Provide data management support through the full clinical trial lifecycle.
• Back up and assist the Lead DM to ensure timeliness and quality.
• Perform data entry and QA of data where needed.
• Develop CRF specifications and coordinate stakeholder feedback.
• Build and maintain clinical databases and documentation.
• Train staff on study-specific CRF, EDC, and related items.
• Review data per the Data Management Plan and generate line listings.
• Coordinate SAE/AE reconciliation and liaise with vendors as needed.
• Support SAS programming and QA of SAS code in DM.
• Identify issues from metrics and audits and assist with resolutions.

Skills

Strong communication

Organizational skills

Self-motivation

Team collaboration

Problem solving

Education

Bachelor's degree or related experience

Tools

Microsoft Office

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.

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, 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

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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.

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