Jobs

• Demonstrate the ability to multi-task and manage STPs across multiple client instances.
• Plan and establish timelines to meet or exceed business expectations for STPs/review schedules.
• Allocate time for investigation and resolution implementation.
• Strong troubleshooting and analytical skills for identification of errors and resolution steps.
• Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all staff.
• Support management of metrics.
• Assist with investigating or resolving issues of quality as directed.
• Suggest process improvements where issues are seen.

Customer Facing

• There are basic customer interface job functions in this position.

Metrics

• Support management for metrics.
• Assist with investigating or resolving issues of quality as directed.

Staff and Financial Management

• Understand implications of activities to project budgets.

Process Improvement

• Suggest process improvements where issues are seen.
• Support Six Sigma process improvement teams.

Training / SOPs

• Reviews training materials for staff.
• Mentor and support other GSS employees in their understanding and adoption of STP to GlobalCODE®.
• Active member of SOP review teams as assigned.

Other

• Lead or assist with special projects as designated.
• Perform other duties as assigned by management.

• Minimum 2-3 years of experience working in clinical trials, laboratory, or specimen management, central lab setup is preferred. Informed consent and regulatory knowledge, molecular biology, clinical pharmacogenomics or biomarker research experience are all a plus
• Proven ability to plan, prioritize, and manage in a fast-paced environment with a high degree of initiative
• Strong drive for process optimization and data integrity
• Excellent communication and interpersonal skills
• Detail oriented, ability to work independently and ability to work/communicate effectively with clients
• Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry
• Ability to work in a rapidly changing environment
• Independently analyze, solve, and correct issues in real time, providing problem resolution end-to-end.
• Strong MS/Office skills in particular with Excel and Word.
• In addition to above, candidates with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities
• Education/Qualifications/Certifications and Licenses