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Project Manager

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Job Summary

Company
Optimus Search
Location
London, London
Industries
Other/Not Classified
Job Type
Full Time
Permanent
Education Level
Unspecified
Job Reference Code
BBBH6990_1497545064
Contact Information
Robert Marrett
Optimus Search

Project Manager

About the Job


Senior CRA - Slovakia - 12m Contract - €35 per hour all-in

Abbott Molecular has an opening for Clinical Research Associate. This position can be field based. The clinical research associate (CRA) designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products. Ensures that the clinical studies are conducted per established policies, procedures, regulations, and Good Clinical Practice (GCP). Participates in the preparation of regulatory submissions and international registration packages

Major Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system.

  • Complies with all policies, established procedures, and regulations related to clinical research.

  • Attends as a member of the cross-functional project team.

  • Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study.

  • Acquires a basic understanding of the principles of the assay and/or instrument and "hands-on" knowledge and skills in performing assigned assays or operating instruments.

  • Participates in the design validation process that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions.

  • Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.

  • Identifies and qualifies clinical investigators and clinical sites.

  • Assists with budgets for clinical studies and initiates payments to clinical sites.

  • Obtains and reviews all required essential documents necessary for study initiation.

  • Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility.

  • Conducts pre-study, initiation, interim, and closeout monitoring site visits and completes site visit reports.

  • Maintains accurate and timely sponsor/site correspondence and communication.

  • Responds to audits and data queries.

  • Prepares project progress reports to keep management and team informed.

  • Assist with clinical sections of regulatory submissions and international registration packages.

  • Assists Regulatory in preparing responses to regulatory agencies' questions regarding the clinical study.

  • May perform other duties as assigned..

**This role may be located anywhere within the U.S.


Qualifications

A bachelor's degree in the biological sciences or related field is required.

Medical Technology MT(ASCP) or equivalent, or certification as a clinical research associate (CCRA) is desirable.

Background:

This position requires an understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and scientific, statistical, regulatory, and compliance requirements for conducting clinical research. Experience at a CRO is a plus.

Minimum of 4 years relevant professional experience may include the following:

2-3 years Laboratory (hospital, research, industrial)

1-2 years Clinical Research

1-2 years Quality Assurance/Auditing

1-2 years Diagnostic Customer Contact

Experience at sponsor site and/or CRO is required.

This position requires good oral and written communication skills, familiarity with desktop computer office software, ability to travel (30-40% US and/or international), and participation in professional activities outside of normal business hours.
 

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