Study Start Up Analyst

Location: Remote

Contract Length: 12 Months (with possibility of extension)

Pay Rate: $24-29/hr

Job Description:

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, AbbVie 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.