20 days old

Study Management Specialist

Kelly Services
Wilmington, DE 19893
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Study Management Specialist** at a prestigious Fortune 500 company working in **Wilmington, DE** **.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title** **:** **Study Management Specialist**

**Pay: $31 per hour**

**Position Summary** :

- 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 company 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 company 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

Provides technical expertise and support for administrative aspects of clinical trials ensuring each study meets its objectives through adequate resources whilst adhering to methodology standards. Liaises with a variety of departments both on a local and/or global level to ensure each study is set up correctly. Provides solutions to a variety of issues relating to the conduct of a study of moderate scope and complexity.

**Ideal Candidate Profile** :

- 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 (current team = 20; FTE and contract)

- Candidates must be local to Wilmington, DE; non-remote position

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-05 Expires: 2020-11-05

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Study Management Specialist

Kelly Services
Wilmington, DE 19893

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