Master Control System Administrator

Company Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description:

· We are currently seeking a strong Master Control System Administrator to join our team.

Overview:

· The Master Control System Administrator (SA) is responsible for effective provisioning, installation/configuration, operation, and maintenance of Master Control Quality Management software as a service (SaaS). This individual works closely with the software provider to resolve system issues, propose enhancements, deploy updates, and test and implement additional functionality within the system.

· The SA will assist project teams and process owners with technical issues in the initiation and planning phases of module implementation, including the definition of needs, benefits, and technical strategy, as well as support of staff in executing, testing and rolling out solutions.

· This individual is responsible for administration of the entire Master Control system as it is implemented at GRAM.

Responsibilities:

· Develop and maintain installation and configuration management procedures.

· Contribute to and maintain system standards.

· Following up on support issues proactively to provide timely updates and resolutions to end users.

· Work with the vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed.

· Work with Validation to apply application version upgrades in a timely manner and configure/add new services as needed.

· User administration, including creating, changing, and disabling user accounts per approved procedures.

· Work with existing process owners to deploy new modules, providing advanced training to support process owners becoming module power users.

· Work to develop reports, based on needs of end users and management, to enable efficient real time reporting.

· Support governmental, organizational, client, and vendor audits as needed.

Candidate Requirements:

· Professional with a minimum of 5 years of experience with systems administration in a pharma, biopharma/biotech, or healthcare environment. Previous Master Control experience preferred. Demonstrated capability in solution deployment and project management skills. Prior experience working in a fast-paced, emerging growth CMO is preferred.

Skills:

· Understand roles and security required when developing or customizing new solutions.

· Understanding of databases and data structures.

· Familiarity with HTML language preferred.

· Able to perform all major day to day administrative hands-on tasks.

· Provide troubleshooting expertise to end users on an ad hoc basis, consulting with Master Control as needed.

· Proficiency in both written and verbal communication and presentations.

· Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

· Ability to work well in a cross-functional team environment.

· Must have proficient computer skills in Microsoft Word, Excel and Outlook.

· Understanding of 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems.

· Understanding of industry requirements and trends toward preserving data integrity, including FDA Guidance for Industry on “Data Integrity and Compliance with cGMP.”

· Familiarity with and previous experience working with Master Control, preferably in a System Administration capacity.

Education and Specific Requirements:

· Bachelor’s Degree

· 3 years of experience as an analyst/administrator for an electronic data management system.

· Prior pharmaceutical industry experience preferred.

· Experience with FDA 21 CFR Part 11 validated systems preferred.

· Excellent problem solving and troubleshooting skills.

· Strong project management and time management skills.

· Demonstrated ability to interact effectively with customers of all organizational levels.

Additional Information

All your information will be kept confidential according to EEO guidelines.