Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summarized Purpose:
Supervises a small global team focused on validating the lab instrumentation in accordance with the European Medicines Agency (EMA) guidelines. This role will oversee the system development lifecycle deliverables created by the team, manage project timelines, participate in client and regulatory inspections, and work closely with various departments and vendors to ensure effective communication, accuracy, and support throughout the project lifecycle.
Essential Functions:
* Provide direction and supervision to assigned technical support staff.
* Participate in client and regulatory inspections
* Review and approve SDLC and validation documentation.
* Gather and write requirements and design specifications for large or moderately complex systems and instrumentation
* Analyze complex issues with requirements and design.
* Define interaction of data with other systems/databases at the company or client companies.
* Perform risk assessments for computerized systems and work with business users to mitigate the risk.
* Work with developers, QA testers, vendors validation team members, and managers to create and analyze required project documentation.
* Provide direction for future releases to software systems; review and approve/reject change requests.
* Create master validation plans, validation test scripts and other validation deliverables.
* Manage assignments to meet deadlines and produce high-quality deliverables.
* Ensure compliance to relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.
* Liaises with internal groups and vendors.
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Job Complexity:
* Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
* Apply company policies and procedures to resolve a variety of issues.
* Exercise judgment within defined procedures and practices to determine appropriate action.
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Supervision Received:
* Normally receive general instructions on routine work and detailed instructions on new projects or assignments.
* Work independently with little guidance or reliance on oral or written instructions and plan work schedules to meet goals.
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Business Relationships:
* Build productive internal and external working relationships.
* Interact frequently with others to obtain or relate information to diverse groups.
Qualifications:
* Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
* Demonstrate leadership skills
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years' experience working in a software development environment, of which at least 3 years must be directly involved in requirement gathering) or equivalent combination of education, training, and experience.
* Knowledgeable of EMA guidelines, 21CFR Part 11 compliance, and other regulatory requirements.
* Experience with requirement gathering and validation of computerized systems
* Firm understanding of system development life cycle and requirements methodology.
* Good MS Office skills.
* Ability to estimate level of effort for small to medium-sized projects.
* Ability to mentor associate level Business System Analyst team members.
* Strong business skills including documentation, presentation, interpersonal, and communication.
* Strong problem-solving and analytical skills.
* Strong planning and organizational skills.
* Ability to interact with relational databases at an intermediate level.
* Solid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC).
* Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are produced.
* Ability to attain, maintain, and apply a working knowledge of applicable SOPs/WPDs, and process maps.
* Demonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary team.
Working Conditions and Environment:
* Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
* For Labs-based staff travel up to 60-80% of time, domestically with extended overnight stays. Light/occasional travel for corporate-based staff.
* For Labs-based staff, exposure to biological fluids with potential exposure to infectious organisms.
* For Labs-based staff, personal protective equipment is required such as protective eyewear, garments and gloves.
* Exposure to fluctuating and/or extreme temperatures on rare occasions.