Job Description:
Purpose:

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

Responsibilities:

• 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.
• Provides input and/or recommendations to Work Instructions and Job Aids related to SSU systems.
• 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 and complies with GCP, Client SOPs and functional area processes.

Qualifications:

• Bachelor's degree or international equivalent is highly preferred or equivalent years of experience required.
• A minimum of 2 years professional work experience; experience in Pharmaceutical-related industry and study start up experience preferred
• 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.
• Competent use of electronic systems. Experience using Vault eTMF or SSU preferred.
• Competent knowledge of clinical trial management systems and procedures.
• Competent use of Excel. Experience with SmartSheet preferred.

Job Type: Full-time

Pay: $30.00 - $30.60 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift

Work Location: Remote

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