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22 days old

Study Management Specialist

Kelly Services
Wilmington, DE 19893
**Study Management Specialist Wilmington, DE**


_Full-time, Contract Position_


_Pay NEGOTIABLE_


**Ideal Candidate Profile:**


+ Bachelors degree is preferred

+ 3-5 years of experience in clinical trials 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

+ High ability to manage priorities and Local Study Team expectations

+ Independent yet able to work cohesively with a team - Candidates must be local to Wilmington, DE; non-remote position


**Responsibilities:**


+ Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of documents. Maintain and close the local TMF ensuring International Conference of Harmonization 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.

+ 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).


**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


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-25 Expires: 2022-08-25

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Study Management Specialist

Kelly Services
Wilmington, DE 19893

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