Senior Clinical Data Coordinator

Employer: PRA Health Sciences

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and are the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

Primary activities include, but are not limited to:

• Accountable for all trial level clinical coding
• Interact and communicate with customers and stakeholders both internal and external to GDMS as well as Sponsor when needed.
• Support the Manual Encoding Leads, as needed, with GDO responsibilities to design, create, validate, review, approve and maintain encoding specifications.
• Working with InForm/ Central Coding/TMS systems
• Coding with MedDRA and WHODrug
• Participate in relevant operational meetings.
• Execute and trigger communications and escalations at the protocol level within the department, within the function, and cross-functionally.
• Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level.
• Support the database lock and interim analysis activities related to encoding.
• Accept and execute special responsibilities related to process maintenance, data quality assessment, and staff training.
• Continually monitor for opportunities to improve efficiency, effectiveness, and quality.
• Performs tasks with minimal guidance from Manager(s).

Qualifications

Associate Degree, RN (or higher) in Medicine, Pharmacy, Nursing, Biological Sciences, or health care-related discipline

Knowledge and Skills:

• Excellent oral and written English language skills.
• Knowledge of regulations and policies applicable to the pharmaceutical industry encoding.
• Understanding of the clinical development process and the value of encoding.
• Knowledge of clinical practice and medical terminology.
• Ability to work cross-functionally and as part of a team.
• Be able to work under pressure in a changing environment with flexibility.
• Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager.
• Ability to coordinate the work of others and influence decision making.
• Exceptional communication skills (oral and written) with the ability to communicate in both the technical and business areas.
• Exceptional organizational and problem-solving skills.

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