Study Management Specialist Job

STUDY MANAGEMENT SPECIALIST needed for a LONG TERM CONTRACT opportunity with Yoh's client located in Wilmington, DE.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is required
- 3-5 years of CTMS (Clinical Trial Management System ) experience, preferably with IMPACT
- Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents

WHAT YOU'LL BE DOING:

- 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 AstraZeneca 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 ie 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 (eg IMPACT, SharePoint etc) and support others in the usage of these systems

WHAT YOU NEED TO BRING TO THE TABLE:

- 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

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- 3-5 years of CTMS (Clinical Trial Management System ) with IMPACT

WHAT'S IN IT FOR YOU?

Work for a multinational pharmaceutical and biologics company having a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.

WHAT ARE YOU WAITING FOR? APPLY NOW!

Yoh, a DayJ2W: CLINICAL

MONJOB J2WNECLIN

Ref: AZNJP

SFSF: LS