Clinical Data Lead

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre 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 the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Please note this role is office based in Scotland

Primary activities include, but are not limited to:

• All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM).
• Responsible for all protocol level start-up, in-life and database lock tasks and activities.
• Interact and communicate with customers and stakeholders both internal and external to GDMS as well as Merck when needed.
• Responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
• Coordinate &/or participate in the execution of user acceptance testing of data management tools.
• Provide inputs into the preparation of the investigator meetings materials and makes him/her available for questions. May present data management instruction at investigator meetings based on business need and management decision.
• Participate in relevant operational meetings to identify and incorporate global operational issues into the study design.
• Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally.
• Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level.
• Coordinate the database lock preparation and monitoring of checks, such as data flow and derivations monitoring, for clinical data repository and triage issues according to report output.
• Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.
• Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level, program level, TA level and department level.
• Performs tasks with minimal guidance from manager(s).
• Support and execute any role or task in the team when needed.

Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs).

Education/Experience (Ex-US , subject to local requirements):

At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline with at least 3 years’ professional experience in clinical data management;

OR

Associates Degree with at least 5 years’ professional experience in clinical data management;

OR

High School Diploma (or equivalent) with at least 8 years’ professional experience in clinical data management.

Knowledge and Skills:

• Knowledge of database structures and available tools to manage, extract, and report data is preferred
• Fluent Oral and written English language skills
• Knowledge of applicable regulations and policies
• Proficient overall working knowledge of the clinical development process
• Good working 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 with both the technical and business areas
• Exceptional organizational, problem-solving and negotiating skills
• Demonstrated excellent project management and leadership skills

Proficient in Microsoft Office, especially MS ExcelBenefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.