Consulting Opportunities

Our client, a pre-commercial pharmaceutical company is in phase III clinical trials. They are using a clinical tracking and material ordering custom application for patient testing and scheduling. This application is the platform they use with their Clinical Research Outsourcing partner.

They are seeking an analyst familiar with the clinical process and clinical applications workflow, requirements and regulatory implications. This is a custom built application so any familiarity with cTMF, eTMS, patient scheduling, CRO communications would be ideal. The system is built on an Access DB so it will likely be replaced. This person will help with the evaluation, selection and implementation of the next gen app.

• 5+ years experience as an Analyst supporting clinical applications within pharma
• Experience documenting clinical requirements and workflow
• Background in playing the intermediary between the CRO and a pharma's clinical department.
• Experience with CSV/regulated systems
• Solid understanding of systems and applications workflow

Job Type: Contract (1008)

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Overview:

• Author key validation documents: Validation Plans, Validation Summary reports, Test Plans etc…
• Advise project and technology teams on validation and data integrity best practices and approaches
• Collaborate with GxP QA on process definition and improvement, author and revise CSV related SOPs
• Coordinate and execute CSV activities (UAT, document reviews) for Quality, Manufacturing, and Lab digital projects
• Liaise with other CSV teams to harmonize and streamline validation practices
• Help support CSV readiness for inspections and audits, support QA and business team during inspection activities

• 5+ years of computerized system validation experience with a primary focus on GxP.
• Proven experience creating sustainable and nimble validation efforts for SaaS/PaaS GxP systems and cloud infrastructure
• Working knowledge of CSV, data integrity and ICH guidance related to the use of computerized systems in Quality and Laboratory environments
• Excellent communication skills
• Demonstrable experience in authoring key validation deliverables such as validation plans, validation reports and validation strategy approaches
• Experience with paperless validation preferred
• Knowledge of Quality, Lab, and Manufacturing systems preferred
• Bachelor's degree in computer science, biotechnology engineering or equivalent

Overview:

The successful candidate will enjoy working closely with users to understand their workflows and needs. They will have a talent for understanding complex problems and designing solutions. They will also be comfortable working in an intense, fast-paced environment. The work done by the software engineering team will dramatically improve the performance and quality of production pipeline, which will accelerate the development of our product.

• Design and develop sophisticated, stable, and maintainable applications to solve real challenges throughout the production pipeline
• Work closely with users to understand the science behind our products, collect their requirements, and design solutions
• Work collaboratively as part of vibrant development team
• Peer-review the work of other developers on the team for quality and accuracy
• Develop unit tests and test scenarios
• Help improve the overall design and architecture of the suite of applications
• Implement automated data analysis and mathematical algorithms

Minimum Qualifications:

• Degree in Computer Science or related technical field or equivalent practical experience
• Degree in Life Sciences or related scientific field or equivalent practical experience
• Strong object-oriented design and software engineering capabilities, including programming experience in modern JavaScript frameworks
• Experience developing or designing large, complex software systems as part of a team
• history delivering software solutions in the pharma/biotech environment
• Comfort collecting requirements from users and translating into solutions
• Experience in multi-tier web development and RESTful services
• Keen ability to translate between scientific, commercial, and technology domains
• Passion to make a difference

Preferred Qualifications:

• Extensive experience in a wide variety of programming languages and techniques
• Data architecture, database design, and query experience
• Familiarity with mobile web development and responsive design
• Understanding of GUI design and usability principles
• Expertise building web applications on ES6 with AngularJS, Bootstrap front-end and Node.js, Express, Sequelize Postgres back-end. We’ll be upgrading the front end this year to Angular with TypeScript.
• Linux admin and cloud computing experience—in particular AWS
• A strong mathematical background with experience in data analysis and algorithm implementation

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Overview:

• Proven experience working with manufacturing leadership for eliciting system requirements.
• Hands-on data architecture within Manufacturing, analytics and process systems.
• Gene therapy manufacturing system experience preferred.
• Computer system validation experience

Job Type: Contract (1001)

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Overview:

• 2-3 years Planview Enterprise One implementation and admin experience
• 5-7 years business and system analysis experience with in project management tools
• Experience working with PMO and Finance department to align requirements
• Experience with O Data Stage II for reporting and analytics within Planview

Job Type: Contract (997)

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Overview:

One of our thriving Life Sciences client is looking to mature their PMO, project review and approval process. This group works closely with Finance to assess and approve large scale capital projects.The ideal candidate will have experience working with finance and accounting teams.

• Oversee the evolution and development of the IT Governance transformation to optimize value and business outcomes incorporating best practices in measuring agile lifecycle methodologies.
• Drives Portfolio-level Information transparency and provides value risk oversight by partnering with PMO, Business, IT, and Product Managers to define and analyze metrics and information related to value delivery.
• Provide active and dynamic leadership to governance transformation initiatives aimed at achieving Takeda’s strategic and financial objectives.
• Serve as a liaison between business units, product portfolio management and the rest of IT in support of operationalizing and scaling lean governance principles

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Overview:

Core Responsibilities:

• Coordinate multiple projects and reconcile the interdependencies among them
• Understand and set project objectives and ensure projects are scheduled to meet deadlines
• Provide strategic guidance to project managers and Technical/Digital Leads
• Identify, manage and escalate risks and issues and ensure corrective measures are identified and addressed to mitigate
• Manage and deliver Stakeholder communication and governance meetings. Develop Steering team presentations and program forecasts.
• Facilitate communication amongst a program’s cross-functional teams
• Achieve goals in a timely manner by prioritizing task and building contingency planning
• Contribute and/or develop system/tools to enable program and resource tracking, trending, forecasting, and decision making.
• Support facilitation of SOW development, reviews and approvals with appropriate management.

• 5 plus years of program management, project management experience implementing and maintaining technology a regulated biotech or Pharma company
• Demonstrated ability to manage program governance and facilitate steering team meetings
• Strong organizational skills with attention to detail
• Ability to effectively communicate and provide clear, candid and transparent descriptions of task, issues, changes, challenges and proposed solutions
• Strong interpersonal skills
• Highly collaborative and comfortable in providing guidance and expertise within dynamic teams
• Comprehensive understanding of project management applications such as MS Project, Excel and Smartsheet

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Overview:

The primary responsibility of the Program Analytics Lead role is to own and drive the effort of designing and building the Analytics and Reporting solution as part of the HANA program. This leader must be a balanced thinker that weighs technical, business, financial and operational perspectives. This exciting, multi-dimensional role enjoys a variety of responsibilities in building out a robust data management and analytics architecture to enable business process execution centered around the SAP S/4 based solution and unlock insights by utilizing capabilities across S/4, Fiori, HANA, BW and other tools.

• Establishes and manages the Analytics team for Magellan including capabilities in Fiori, HANA, BW or B/4 and EDH by leveraging both internal resources and external partners.
• Works collaboratively with the key stakeholders.
• Leads the design and build of the solution architecture for data management and analytics.
• Defines the analytics approach to support the interim state during the project timeline.
• Partners with scrum teams to coordinate the activities and resources to capture analytics needs and activate the standard reporting and analytics capabilities.
• Partners with PMO and scrum masters to apply the lean and agile principles in the delivery of the solution.

Job Type: Contract (1003)

Overview:

• Create / follow/enhance a repeatable framework for a project structure to account for all IT required tasks
• Create and manage detailed project plans for projects with clear identification of resources, dependencies, risks and milestones.
• Prior experience supporting core business groups is a must (Sales, Marketing, Accounting & Finance, etc...)
• Identify and manage project risks; escalate as needed for resolution. Improve project management processes and increase efficiencies
• Manage relationships with cross-functional project partners/service providers
• Demonstrate ability to create executive summaries and reports.
• Any experience working in an Agile environment is a big plus

• Evaluate new tools and techniques to create innovative and practical security solutions
• Lead project management activities associated with the implementation of new or upgraded hardware and software components of security enterprise solutions including project planning, execution and closeout.
• Support vulnerability management activities
• Investigate security incidents and escalate as required; operate software/hardware to protect information systems and all infrastructures.
• Create, develop, maintain and provide guidance on the implementation of information security across the organization through the use of policy, procedures and standards
• Provide support and evidence when required in respect of all audit activity undertaken within the environment to include liaising directly with auditors.
• Work with the Associate Director of Information Security to manage relationships with external vendors, ensuring that the performance and provision of services are meeting expectations.
• Attend Global Change Advisory Board and review proposed changes to identify gaps in controls or changes that introduce an unacceptable level of risk
• Identify security design gaps in existing and proposed architectures and recommend changes or enhancements
• Strive for continuous improvement across the delivery of the organization’s security services
• Assist and train junior team members in the use of security tools, the preparation of security reports and the resolution of security issues

• BS/BA in Computer Science, IT, Information Systems or 10+ years’ experience in IT Security or IT infrastructure disciplines
• Relevant professional certifications desirable e.g. CISA, CISM, CISSP,
• 5+ years’ experience working in a similar role is desirable
• Experience in installation, configuration and troubleshooting of tools such as firewalls, IPS, malware protection, Log Management, MFA, NAC, and vulnerability management
• Good understanding of Privileges and Rights in Windows AD
• Possess a working knowledge of computer network vulnerability and compliance scanning/analysis software (e.g. Nessus).
• Experience of Privileged Access Management Solution implementation an advantage
• Experience of ICS an advantage
• Knowledge of network security architecture concepts including topology, protocols, components, and principles (e.g., application of defense-in-depth).
• Knowledge of Application Security Risks (e.g. Open Web Application Security Project Top 10 list).
• Knowledge of common IT industry and IT security standards (e.g. ISO 27001, 27002, NIST800-53, CIS, COBIT, 21 CFR Part 11, ITIL)