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Clinical-Scientific - Clinician

Online/Remote - Candidates ideally in
Cambridge - Middlesex County - MA Massachusetts - USA , 02139
Company: Pioneer Data Systems
Contract, Remote/Work from Home position
Listed on 2021-07-28
Job specializations:
  • IT/Tech
    SAS Programmer, Data Analyst
  • Science
    Biotech Clinical Research
Job Description & How to Apply Below
Position Details:

Our client, a world-leading Pharmaceutical client in Cambridge, MA is currently looking for a Drug Safety Associate / Pharma Industry (REMOTE WORK) to join their expanding team.

Job

Title:

Drug Safety Associate / Pharma Industry (REMOTE WORK)


Duration: 12 months contract, extendable up to 36 Months

Location:

Cambridge, MA



Note:



The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the company group medical insurance plan



Job Description:



We would like to hire for a total of 6 clinical positions for three upcoming trials with a total >4600 randomized subjects in a global study with the primary scope of work: clinical data review, protocol deviation review and categorization. Narrative review will be needed later.

Independently review large scale data listings from a clinical/medical perspective

Post queries in EDC system and follow all queries to resolution

Review serious adverse event narratives and compare to clinical database

Protocol Deviation and subcategorization

Clinical Narrative Review

Clinical/medical review of subject data; reconciliation of data between multiple sources

Position will report to Clinical Team (under Clinical Data Review Team)

Liase with Data Management Team

3-5 years clinical scientist/clinician/monitoring/CRA experienced required

Prior CRA or Prompt (Remote) Monitor experience preferred, but not mandatory if strong in data review or other skills and demonstration of quick learner.

Graduate degree preferred but will consider undergraduate degree with significant experience

Strong clinical research background-Ability to think critically and consider the data comprehensively

Prior InForm EDC experience a must or very quick learner for data platform technology systems

Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date)

Moderate level of tech savvy to learn new systems quickly and to be able to navigate independently in different systems

Basic understanding of how data points from different field/CRFs interact and how data collection impacts analysis

Strong attention to detail

Ability to work independently and as part of team

Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style)

Access to internal CITRIX platform (Jreview) will be required to obtain data review listings

Review tracking required (Excel format)

Other internal Pharmaceutical systems will be used a document repositories

Comments:

At least 3-5 years plus Pharma experience

MS Excel proficient

Strong clinical background- infectious disease experience preferred but not required.

Strong and independent critical thinking



Minimum Education:



Bachelor degree

Independently review large scale data listings from a clinical/medical perspective

Post queries in EDC system and follow all queries to resolution

Review serious adverse event narratives and compare to clinical database

Protocol Deviation and subcategorization

Clinical Narrative Review

Clinical/medical review of subject data; reconciliation of data between multiple sources

Position will report to Clinical Team (under Clinical Data Review Team)

Liase with Data Management Team

3-5 years clinical scientist/clinician/monitoring/CRA experienced required

Prior CRA or Prompt (Remote) Monitor experience preferred, but not mandatory if strong in data review or other skills and demonstration of quick learner.

Graduate degree preferred but will consider undergraduate degree with significant experience

Strong clinical research background-Ability to think critically and consider the data comprehensively

Prior InForm EDC experience a must or very quick learner for data platform technology systems

Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date)

Moderate level of tech savvy to learn new systems quickly and to be able to navigate independently in different systems

Basic understanding of how data points from different field/CRFs interact and how data collection impacts analysis

Strong attention to detail
 
 
 
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