Profil Institute IT System/Project Manager in San Diego, California

Summary: The IT System/Project Manager is a technical hands-on role that reports to the Director, IT Services. S/he coordinates daily IT operations and is responsible for the quality of operations. This includes monitoring of systems, managing the help desk, expediting the resolution of issues, creating Standard Operating Procedures (SOPs) and monitoring quality. S/he will also be the administrator for some systems and will need to perform helpdesk duties when needed. Will assist in the development, implementation, administration, and documentation of systems/project plans, user requirements, and test plans to ensure key projects are completed in a timely fashion. Performs duties in accordance with company’s values, policies, and procedures.

Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.

  • Contributes hands-on to core IT functions and understands their operation.

  • Helps manage daily IT operations including management of Managed Service Provider (MSP).

  • Sets up and performs system quality checks, monitoring and resolving issues. Makes sure all systems are patched and current as per schedule.

  • Holds the technical ability to assist helpdesk staff with resource shortages when they occur and to expedite issue resolution.

  • Provides technical knowledge through entire project lifecycle, including requirements analysis and documentation, solution development, project planning and launch, implementation, and post-launch support.

  • Creates and updates relevant Standard Operating Procedures (SOPs).

  • Provides administrative support to department (purchasing, contracts, etc.).

  • Working with cross-functional teams, helps manage concurrent, complex key projects. Experience with NetSuite, SharePoint, Salesforce, electronic trial master files (eTMF), clinical trial management system (CTMS), software development, and/or IaaS/SaaS a plus.

  • Helps define, develop, track, and communicate project schedules and deliverables to the project stakeholders.

  • Proactively takes corrective action to address issues, schedule variances, and resource utilization issues.

  • Resolves any issues and solves problems throughout the system/project life cycle.

  • Available evenings and weekends if needed or scheduled.

  • Assists the Director, IT Services as needed.

Supervisory Responsibilities:

Coordinates with onsite IT staff and service providers. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor's degree from a four-year college or university with 5+ years IT system/project management experience and 2+ years management experience in a pharmaceutical, CRO, or medical device company, or related organization and/or an equivalent combination of education and experience. Good Clinical Practices (GCP) experience preferred. Hands-on problem solver and natural team leader. 21 CFR Part 11 compliance experience a plus. Helpdesk Technician experience a plus.

Skills, Knowledge, and Abilities:

Project management abilities. Ability to independently see projects through to completion while maintaining ongoing and proactive communication with affected team members. Wide range of technology experience. Able to effectively manage and develop support staff.

Language Ability:

Able to communicate at all levels in a clear, cooperative and concise manner. Ability to read, analyze, and interpret complex documents.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills:

To perform this job successfully, an individual should have advanced skills in Excel, SharePoint Online, and the current Microsoft Office Suite. Must have ability to quickly learn and use new software systems.

  • Windows Active Directory administration

  • Office 365 email/SharePoint Online administration

  • Single Sign-On (SSO) familiarity. Okta Universal Directory experience preferred.

  • Experience writing Change Control, SOPs/Work Instructions (WIs)

  • GCP/21 CFR Part 11 experience is preferred

  • Understanding of TCP/IP protocols

  • Experience managing vendors/resources

  • Working directly with clients on project design requirements before planning, reviewing with management, implementing, and transitioning to helpdesk team

  • Able to learn and train others on new technologies as needed

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; work in high, precarious places and fumes or airborne particles. The noise level in the work environment is usually quiet to moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to walk and stoop, kneel, crouch, or crawl.

External Company Name: ProSciento, Inc.

External Company URL: http://www.profilinstitute.com/