Kelly Services has an opening for a Clinical Document/Specialist Study Management in Wilmington, DE. This is a one-year contract assignment and requires all work be done on-site, no remote option. The Clinical Document Specialist has 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 Harmonization Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements and supports 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 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 (not for international studies).
Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc.) and support others in the usage of these systems
Bachelors degree is preferred
3-5 years of experience in clinical trial document management and regulatory documents is required; Veeva experience a plus
Accountable and inquisitive; thinks "outside the box"
Must be methodical, compliant to processes yet flexible when needed
Independent yet able to work cohesively with a team
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
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Perks of being a Kelly employee:
Weekly electronic pay
Access to more than 3,000 online training courses though Kelly Learning center
Group rate insurance options available immediate upon hire*
Service bonus plan and holiday pay*
Online application system
Never an applicant fee
*perks to be received upon meeting eligibility requirements
With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.