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Drug Safety Associate - DMC

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About the role

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Drug Safety Associate DMC

 

This position is primarily responsible for managing all Data Monitoring Committee (DMC)

 

Purpose of the Role

·         Manages project in a timely manner in adherence with ICON’s SOP’s, ICH, GCP and appropriate regulation and liaise with other departments as necessary.

·         Delivers projects in accordance with the contract, timelines and study budget

·          Identifies out of scope activities and initiates budget change orders and contract amendments

·         Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings

·         Ensures all necessary study specific training is provided to study team to improve performance and knowledge. Provides coaching / mentoring as necessary.

·         Develops and maintains all trial documentation (ie Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)

·         Performs user acceptance testing  of electronic endpoint adjudication system

·         Performs data reconciliation

·         Serves as the primary study contact for client and internal and external study teams.

·         Prepares meeting agenda and facilitates the completion and distribution of meeting minutes

·         Conducts project/system specific training to committee members

·         Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues.

·         Participates in bid defense and new proposal review activities as necessary

·         Participates in internal, client, and regulatory audits

 

Role Requirements

 

·         EU: prior relevant clinical research industry experience

·         Basic knowledge of applicable global, regional, local clinical research regulatory requirements; ie Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs), or the ability and willingness to gain this knowledge.

·         Highly developed problem solving skills

·         Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors

·         Knowledge of medical terminology

·         Excellent communication and documentation skills

·         Excellent organizational, time management and problem-solving skills

·         Strong sense of responsibility and dedication

·         Attentiveness to detail and accuracy; ability to maintain quality standards

·         Ability to follow instructions/guidelines, utilize initiative and work independently

·         Proven ability to multi-task, manage competing priorities and timelines

·         Due to the nature of this position it may be required for the employee to travel.  Therefore, dependent on the employees’ location, the employee may be required to possess a valid Drivers license.

·         Bachelors’ Degree or local equivalent in medicine or science

·         Licensed nursing professional or similar medical/scientific certification


Benefits

 

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

 

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. 

 

What’s Next?

 

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

 

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

 

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