Drug Safety Associate - DMC

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