Consultant, Technology Solutions
Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively and push beyond the status quo? Join Halloran Consulting Group, Inc. today!
Halloran is looking for a Consultant to join its Technology Solutions practice area. As a Consultant, Technology Solutions you will provide subject matter expertise to support a variety of client engagements focused in the area of life science technology enablement, leveraging your understanding of software used to support clinical trials and your strong computer validation skills.
- Assess and audit client computer systems and infrastructure for compliance gaps (e.g. 21CFR Part 11, GAMP5, data integrity, related guidance) and inefficiencies; develop and implement remediation plans
- Lead and support identification and implementation of regulated software for clients including activities such as system selection, software vendor auditing, business requirement development, validation planning, validation deliverable authoring/ execution, risk assessment, data migration, and training
- Translate the strategic goals of multiple projects into tactical and operational activities, balancing competing priorities in making recommendations.
- Independently support daily project activities with a flexible, proactive and creative mindset, including but not limited to:
- Establish and adjust timelines, milestones and resource needs
- Monitor and report project status (e.g. deliverable progress, budget, schedule, resources, and risks)
- Identify the impact of timeline and scope changes against the project plan
- Provide ongoing updates to internal and external project team members/stakeholders via dashboards, presentations, and other appropriate communication methods
- Identify, mitigate, and escalate project risks; support timely resolution
- Provide early input and participation in project scope definition and proposal/statement of work authoring for a variety of technology projects to support client’s clinical trials
- Participate in and/or lead meetings to effectively facilitate decisions, issue resolution, routine project updates to the client, building relationships, credibility, and trust
- Support planning and execution of workshops (e.g., process mapping, risk analysis, user requirement development or other brainstorming sessions)
- Participate in Halloran initiatives to drive standardization (e.g. templates, tools, content re-use) to increase efficiency within the Technology Solutions group
- Participate in internal activities such as blogs and attendance at industry meetings when opportunities arise
- Identify expansion or new opportunities within existing client engagements by leveraging previous experiences and insights
- Bachelor’s degree in a life science-related discipline such as Biomedical Engineering, computer science, or demonstrated equivalent and a minimum of eight years of experience in a technology-related role in an FDA-regulated company, including five plus years of software testing/ validation experience
- Knowledge of computer systems relied on to support clinical trials and quality management in the Biomedical industry and the data contained therein
- Strong understanding of 21CFR Part 11, GAMP5 and best practices related to data integrity controls
- Ability to work creatively and analytically to manage multiple priorities and tasks using logical and efficient processes while still keeping a high level of attention to detail and quality of work throughout the entirety of the project life cycle
- Familiarity with Smartsheet and other project management tools
- Understanding of tools used in Software Development Lifecycle management such as JIRA, Confluence etc.
- Experience in IT compliance beyond FDA predicate rules and 21CFR Part 11 including ISO27001, GDPR, HIPAA, Annex 11, HITRUST
- Lean Six Sigma, Lean Business Process, and/or PMP certification
- Understanding and application of Good Clinical Practice (GCP) and clinical regulatory compliance
Halloran Consulting Group, Inc. Perks:
- Comprehensive Medical, Dental, and Vision Insurance
- 401(k) Plan for all Full-Time Employees
- Commuter Benefits
- Reimbursements for Health & Wellness Programs and Memberships
- Self-Managed Vacation Policy
The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
Halloran Consulting Group, Inc. is an equal opportunity employer. It is the policy of the Company to prohibit discrimination and harassment of any type and to afford equal employment opportunities to employees and applicants, without regard to race, color, religion, sex, national origin, age, disability, genetic information, gender identity or expression, or veteran status. The Company will conform to the spirit as well as the letter of all applicable laws and regulations. The Company will act to employ, advance in employment and treat qualified Vietnam era veterans and disabled veterans without discrimination in all employment practices.
*External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.