Clinical Document Specialist

1 week ago

Remote, Canada ICON Full time

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.

**General Summary**:
Develops/maintains study documents and utilizes company systems to manage clinical/biomedical studies. Provides administrative support to project team members in clinical operations and project management. Works with the project team to ensure that projects are completed in accordance with contract and client expectations.

**Primary Responsibilities**:

- Organizes project team and client meetings including scheduling, meeting materials, binders, agendas and meeting minutes.
- Organizes study information and supplies. Generates and maintains organizational charts, team calendar, newsletters, mass mailings, project specific information including but not limited to process flow charts, contact lists, holiday lists, study website, mailing labels. Tracks, dispatches and maintains study supplies following applicable company processes.
- Manages internal and client project reporting. Generates and reviews for accuracy reports to facilitate project status and financial reporting. Completes system updates and queries.
- Supports project manager with financial tasks. Has oversight of purchase order process including creating and processing purchase orders and processing study invoices. May process Investigator payments.
- May support preparation of study files by maintaining and distributing project documents. Ensures documents within the electronic trial master file comply with filing/naming guidelines and have the correct status.
- Uses the learning management system to assign project-specific training to team members and tracks training compliance.

**Responsibilities**:

- Executes advanced administrative tasks.
- Provides basic information to team.
- Working independently, under general supervision, delivers on assigned tasks.
- Regularly meets timelines/quality and cost expectations for a given for a task/project.
- May provide guidance to lower level staff.

**Qualifications**:

- In-depth knowledge of applicable systems/processes
- Working knowledge of internal control procedures and standard operating procedures (SOPs)
- Good written/verbal communication skills
- Read, write and speak fluent English, fluent in host country language (French)
- Basic knowledge of the company’s industry and service offerings
- Awareness of applicable regulations
- Good business etiquette skills
- Excellent task management skills

**Education & Requirements**:

- Associate’s degree or international equivalent in business, finance, health sciences or related field
- 2 years’ experience in clinical project administration or other relevant

**Benefits 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.

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