OneMain Financial Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You’ll Do:

• Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.

• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.

• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.

• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.

• Provides system support (i.e. Activate, CTMS & eTMF).

• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.

• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.

• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.

• Maintains vendor trackers.

• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.

Education and Experience Requirements:

• Bachelor's/ Masters degree in Life Sciences/ Pharmacy

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years).

Knowledge, Skills and Abilities:

• Ability to work in a team or independently as required

• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively

• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

• Strong customer focus

• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines

• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

• Excellent English language and grammar skills and proficient local language skills as needed

• Good presentation skills

• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems

• Ability to successfully complete PPD clinical training program

• Self-motivated, positive attitude with effective strong interpersonal skills

Working Conditions and Environment:

• Work is performed in an office/ home office environment with exposure to electrical office equipment.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.