TA Business Partner
- Icon Strategic Solutions
About the role
As a (TMF Specialist II) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities:
- Maintain effective communication with clinical trial teams and CRO staff throughout trial start-up, maintenance, close-out, and archive
- eTMF Health: Manage open Quality Issue (QI) lists for assigned trials to ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated.
- Closes and reassigns QIs as necessary.
- eTMF Health: Manage Expected Document Lists (EDL) and counts for the life of assigned trials partnering with the Clinical Trial Team (CTT) and CRO team.
- Escalate non-compliance with EDL business process to the eTMF Manager as needed.
- eTMF Health: Provide scheduled and ad-hoc analysis and metrics on TMF Health for eTMF Managers and CTT/CRO teams on assigned trials.
- Be responsible for TMF activities for assigned trials including:
- Supporting TMF document filing into Moderna eTMF system.
- Maintaining the naming and filing guide specific to TMF documents.
- Conducting ad-hoc quality checks and review of document content uploaded into the eTMF.
- Responding to inquiries regarding TMF management and contents.
- Supporting inspection/audit preparation and remediation activities.
- Attend departmental and trial-specific meetings and discussions, as required.
- Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements.
- Performs general administrative tasks related to their assigned trials.
- Completes other TMF document-related tasks as required by the eTMF Manager or department head.
Qualifications:
- Minimum B.A./B.S. degree preferably in science or healthcare.
- 2+ years work experience, preferably in a relevant clinical research setting.
- 1+ years experience in eTMF document management (in a specialized team or as a member of a clinical trial team) is an advantage.
- Strong organizational/prioritization skills for the management of workload and attention to detail.
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/21/2023
Summary
From Clinical Trial Assistant to Clinical Operations Manager, Adrienne Purdy shares her journey.Tell us about you role and what you do at ICON? I have been at ICON since 2013 and I have been growing
by
Adrienne Purdy
Teaser label
Our PeopleContent type
BlogsPublish date
11/05/2014
Summary
Vijayakumar discusses interacting with the SAS community and representing ICON at National and International conferences. I’ve worked for ICON for the last four years and am currently a Senior SAS Pr
Similar jobs at ICON
Salary
Location
United Kingdom
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Other
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-113202
Expiry date
01/01/0001
Author
Jack FisherAuthor
Jack FisherSalary
Location
Chennai
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Chennai
Business Area
ICON Strategic Solutions
Job Categories
Other
Job Type
Permanent
Description
As a (Senior System Support Specialist) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-112390
Expiry date
01/01/0001
Author
Swathy AnandanAuthor
Swathy AnandanSalary
Location
Belgium
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Belgium
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Other
Job Type
Permanent
Description
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, biotech
Reference
2024-112298
Expiry date
01/01/0001
Author
Vanessa VerdicktAuthor
Vanessa Verdickt