Job Title Study Management Specialist
Job Location Wilmington, DE
Duration: 12 Months+

Job Description:

• 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

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 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.
• 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

Best Regards,

Ruchii Mathur

Sr. LifeScience Recruiter

Zenith LifeScience LLC

51 Cragwood Road Suite 306

South Plainfield, NJ 07080

Cell No: (848)8004753

Job Type: Contract

Pay: $45.00 - $50.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Wilmington, DE 19897: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Contracts: 1 year (Preferred)

Work Location: In person

Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.