Senior Clinical Data Associate

Precision Medicine Group, LLC.; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Precision Medicine Group, LLC. is seeking a Senior Clinical Data Associate in Bangalore to provide data management support across the clinical trial lifecycle.

The role involves working with SOPs/WIs, regulatory directives, and project guidelines, with potential involvement in database development and testing under supervision. Requirements include 5+ years of experience, a Bachelor’s degree, and strong MS Office skills; knowledge of CDISC standards and MedDRA/WHODrug is a plus.

Qualifications

• 5+ years of experience in data management for clinical trials.
• Bachelor's degree or an equivalent combination of relevant experience.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Support the Lead DM as a back-up and team member to ensure continuity and timely task delivery.
• May perform data entry for paper-CRF studies and quality control of data entry.
• Assist in developing CRF specifications from study protocol and coordinate reviews from stakeholders.
• May assist in building clinical databases and conducting UAT on database builds.
• Review data according to the Data Management Plan and generate line listings and reports.
• Coordinate with sponsors, vendors, and project teams on data-related deliverables.

Skills

Data management

Clinical trials

SAS programming

Microsoft Office

Education

Bachelor's degree or equivalent

Tools

SAS

EDC

Job description

Location: Bangalore, Karnataka, India
Category: Clinical Trial Services
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 7158

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, 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
• Bachelor's 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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