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Clinical Scientist

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United Kingdom

Offer summary

Qualifications:

Experience in medical data review, Previous experience in clinical trials, Data management experience in life sciences, Familiarity with TA in healthcare.

Key responsabilities:

Prepare a medical data review plan
Develop study-specific Table of Contents if needed
Review Safety TFLs regularly
Prepare Safety Slide Deck for review
Summary of safety data findings

Lifelancer Information Technology & Services Startup https://lifelancer.com/

11 - 50 Employees

See more Lifelancer offers

Job description

As a Clinical Scientist you will be joining the worlds largest most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

Preparation of a medical data review plan

o Determine data retrieval strategies that are required per MRP/protocol

Development of a study-specific Table of Contents (TOC) if needed, including core TFLs and compound-specific TFLs

o Provide support and suggestions on how to best process data available in the clinical database to serve compound/study needs

Review Safety TFLs at a frequency as specified in the data review plan

Develops a Safety Slide Deck (SSD) for cross functional review with specific attention to:

o Adverse Events (TEAE, Related TEAE)

o Treatment Emergent Serious Adverse Events (TESAE)

o Adverse Events of Special Interest (AESI)

o Worst Post Baseline Laboratory Shift Tables

o laboratory abnormalities

o Important medical protocol deviations

o Study Status Summary Table

o AE Summary

o SAE Summary

Query identifiable safety related medical discrepancies or requests for clarification in the appropriate EDC

Prepare a summary of the safety data review that will include:

o Data reviewed

o Data safety findings observed

o A summary of data cleaning requests / observations

o Any input from stakeholder review

Additional Data Review or Compilation

Review patient-specific and overall safety data presented in the clinical study report (CSR)

Prepare the medical protocol deviations for cross functional review

You are:

- Experienced in medical data review

- Previous experience in clinical trials and clinical trial set up

- Data management experience in life science /pharma

- Experience in one of the following TA: cardiovascular/renal, ophthalmology, cell and gene therapy and oncology

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/ecfb0dccf734996098b346df18235850