Title: Specialist Study ManagementLocation: Wilmington, DEPay Rate: $40-$43 per hour.Contract Length: 12 monthsDescription:
Bachelor’s 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.
-Candidates MUST be able to work in the Wilmington office a minimum of 3 days per week.
Responsibilities:
Own and maintain quality for the study file as the local study team TMF owner.
responsible for site communications and other portal management
running and analyzing reports from multiple systems
Responsible for Vendor Management
Handle requests for CTMS updates
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
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Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
