Ref #: 25737

Employment type: Permanent - Full-Time

Location: US - MD (Remote)

Posted: 10-Dec-2020

Description

WHO WE ARE:

At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.

PRIMARY RESPONSIBILITIES:

• Ensure ESR management is conducted in a quality manner within the ESR
registry and management tool (Evidence Connect)
• Ensure completeness of documentation in Evidence Connect to enable teams
to make effective business decisions
• Manage set up of Investigator Safety letters (ISLs), Clinical Trial Management
System (CTMS) and SAP and D-code set up
• Request ISL gap fill/backfill reports
• Manage Investigator Brochure distribution and mass communications to ESR
Sponsors
• Manage PO set-up post execution of research agreement
• Manage the IND Cross Reference Letter request process with Regulatory Affairs
• Manage drug order process and related data entry in Evidence Connect
• Manage Local Review and Evaluation Group (LREG) Proposal review process
including Evidence Connect workflow
• Provide execution and operational expertise within allocated area of
responsibility
• Provide input into functional work including training activities and development
of procedures, guidance and ways of working and capability development
• Special projects as assigned to support the Medical Evidence Delivery team

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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