Drug Safety Associate - DMC
About the role
This vacancy has now expired. Please click here to view live vacancies.
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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