Specialist Study Management

US Tech Solutions; Wilmington (DE); On-site; USD 70,000 - 95,000; Full time

Job summary

A global staff augmentation firm is seeking a qualified candidate to manage clinical trial documentation and ensure compliance with regulatory standards. The role involves setting up and closing Trial Master Files, supporting study documentation, and working with electronic systems for regulatory submissions. The ideal candidate will have a Bachelor's degree and 3-5 years of relevant experience, with strong organizational skills and the ability to work collaboratively in an international team.

Qualifications

• 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents.
• Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
• Excellent communication and ability to work in an international team environment.

Responsibilities

• Set-up, maintain, and close the local Trial Master File (eTMF) and Investigator Site File.
• Support the production and maintenance of study documents, ensuring compliance with the Client Authoring Guide.
• Contribute to electronic applications/submissions by handling clinical-regulatory documents.
• Maintain tracking information in Client tools like IMPACT and SharePoint.

Skills

Experience with electronic trial master file system(s)

Working knowledge of the Clinical Study Process

Good verbal and written communication

Ability to develop advanced computer skills

Good interpersonal skills

Excellent organization and time management skills

Team oriented and flexible

Education

Bachelor’s degree

Tools

SharePoint

IMPACT

GEL

GDL

Job description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.

We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well.

Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.

Job Description

• Bachelor’s degree is preferred
• 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is required
• Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.
• Contribute to the production and maintenance of study documents, ensuring template and version compliance.
• Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the Client Authoring Guide for Regulatory Documents to support publishing in GEL
• Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
• Set-up, populate and accurately maintain information in Client tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems

Skills and Competencies

• Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
• Working knowledge of clinical study documents
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Good verbal and written communication
• Good interpersonal skills and ability to work in an international team environment
• Willingness and ability to train others on study administration procedures
• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Integrity and high ethical standards

Qualifications

• Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.