Clinical Development Operations Subject Matter Expert and support for clinical trial related systems, with focus on SSU activities

Supports SSU Business with maintaining customized Expected Document Lists, study specific milestones, and study specific tasks

Proactively identify and communicate issues impacting deliverables

Supports maintenance of ICF country templates, ISF templates, and Study Start Up Package templates in Vault Clinical

Contributes to system enhancement requests and works with SSU Operations Management to assist with UAT and implementation

If assigned, triages and provides answers to stakeholder system-related questions

Participates in stakeholder SME and cross-functional meetings and maintains a positive working relationship with internal/external customers and colleagues

Provides suggestions and feedback to line manager regarding issues or potential improvements and participates in functional area continuous improvement projects and/or work streams

If assigned, supports with organizing Team Meetings and minute taking

Provides audit and inspection preparation support for SSU related deliverables

Qualifications :

Bachelor s degree or international equivalent is highly preferred or equivalent years of experience required

A minimum of 2 years of study start up experience from a sponsor or CRO

Experience working with remote/virtual teams

Demonstrates analytical, critical thinking and organizational skills

Ability to independently perform multiple tasks and projects at the same time

Good communication skills (oral and written) and proven effective, collaborative interactions with colleagues

Interpersonal skills with the ability to communicate with clarity, flexibility, and adaptability to changing requirements

Experience using Vault eTMF or SSU

Competent knowledge of clinical trial management systems and procedures

Competent use of Excel; experience with SmartSheet preferred

Pay Scale:

Dependent on Experience

$23.60 - $29.50

R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer.