Scientist

calyx; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Benefits offered by this job

Medical plan

Personal Accident Insurance

Life Insurance

Critical illness cover

Salary structure & Provident fund

Gratuity scheme

Internal growth & training

Job summary

Perceptive in Hyderabad is seeking professionals to support documentation and imaging parameter standardization for multi-center clinical trials. You will author internal and external materials, review project documents, and prepare training content for investigators, CRAs and clients.

The role involves collaborating on imaging QA, aiding in application development, and participating in reviewer training. The position offers growth opportunities within a supportive framework.

Qualifications

• Author internal and external facing documents and material such as imaging parameter guidelines to standardize techniques across multi-center trials.
• Review and input to project related documents including Project Plan, Site Operations Manual, Independent Review Charter.
• Create training material and present to investigators, CRA, and client on imaging parameters and QA.
• Review requirement specifications of analysis applications and customize image viewing/analysis tools.

Responsibilities

• Independently author internal and external facing documents and material such as Standardized/Harmonized imaging parameters.
• Review and provide input to project related documents including Project Plan and Site Operations Manual.
• Prepare and conduct internal and external trainings with supervision, creating PowerPoint slides and site guides.
• Support application development by reviewing requirements and tailoring imaging tools.
• Conduct User Acceptance Testing and participate in Independent Reviewer Trainings.
• Review CVs of potential independent reviewers and monitor reviewer performance.
• Identify non-conformances, review audit findings and assist with corrective actions.
• Participate in client meetings and communicate risks and mitigations to stakeholders.
• Translate and communicate knowledge across specialisms to ensure consistent delivery.

Job description

We're on a mission to change the future of clinical research. At Perceptive, we help the biopharmaceutical industry bring medical treatments to the market, faster. Our mission is to change the world but to do this, we need people like you.

Apart from job satisfaction, we can offer you:

HEALTH

• Medical plan for you and your dependents.
• Personal Accident Insurance
• Life Insurance
• Critical illness cover

WEALTH

• Salary structure and Flexi basket
• Provident fund of 12%
• Gratuity scheme

YOURSELF

• Internal growth and development programs & training

Responsibility

• Supporting Activities
• Document Development
  • Independently author internal and external facing documents and material such as:
    • Standardized/Harmonized imaging parameters - Image Acquisition Guidelines (e.g., develop imaging parameters for specific clinical protocols to ensure standardization of imaging techniques in multi-center trials)
• Document Review
  • With supervision - Review and provide input to relevant project related documents such as:
    • Project Plan
    • Site Operations Manual, if requested
    • Independent Review Charter
    • Image QC and processing instructions (QC Form)
    • Reviewer Manual, if applicable
    • Clinical Data Transfer Instructions, if applicable
• Prepare and conduct internal and external trainings
  • With supervision:
    • Create training material for and present to investigator sites, CRA and client (as needed) such as PowerPoint presentation, site guides on assessment criteria and imaging parameters.
    • Create training material for and present to internal team on image acquisition parameters, quality control and image processing, e.g. image operations
• Support application development
  • With supervision
    • Review requirement specifications of analysis application (including eCRF) and associated applications, and customization of relevant image viewing/analysis tools
• Conduct User Acceptance Testing
• Participate in Independent Reviewer Selection
• Review CVs of potential independent reviewers
• Prepare and conduct Independent Reviewer Trainings
  • With supervision - prepare and conduct Independent Reviewer Trainings, including:
    • Prepare Independent reviewer Training PowerPoint slides
    • Review/Edit training associated documentation
    • Select/Prepare training and testing cases for reviewer training
    • Lead training of independent reviewers on the use of imaging software, analysis applications, and implementation of the review criteria
  • Independent Reviewer Performance Monitoring
    • With supervision perform quality control and evaluation of the results of the independent review and provide necessary guidance and feedback to independent reviewers
• Quality
  • Identify non-compliances and non-conformances
  • Review audit findings, determine the risks associated with those findings and ensure that corrective actions are carried out
• Client Meetings
  • Participate in project related client meetings
• Communication
  • Effective and professional communication with internal and external stakeholders; act as a translator as needed
  • Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation.
  • Actively maintain and disseminate knowledge in one or more identifiable specialisms.

Come as you are.

We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.