Consulting Opportunities

Overview:

• Define overall validation strategy and approach for IT Quality/Clinical CSV projects in a digital context (cloud, automation, AI) and in alignment with our QA policies.
• 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 GCP QA on process definition and improvement, author and revise CSV related SOPs
• Coordinate CSV activities (UAT, document reviews) for Quality and clinical systems projects
• Provide training on our validation process and templates
• Oversee CSV readiness for inspections and audits, support QA and business team during inspection activities

• 8+ years of computerized system validation experience with a primary focus on GCP, GVP and GLP.
• 5+ years of validation experience providing coaching and mentoring to CSV engineers/tech writers and coordinating validation efforts within larger projects
• Proven experience in leading 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 clinical trials
• Experience supporting regulatory inspections related to computerized systems
• 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 Veeva preferred
• Bachelor's degree in computer science, biotechnology engineering or equivalent

Overview:

• Specific duties include, but may not be limited to:
• Review adherence to and implementation of change management methodologies.
• Draft and define the Validation Bundle including VMP, URS, UAT, SDS, TM, VSR and Validation Strategy and coordinate with various stakeholders/third party vendors for IQ, OQ and PQ.
• Assist in drafting, planning, implementing, and documenting user acceptance testing.
• Possess expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
• Generate test protocols to validate new or previously validated systems changes/maintenance
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.
• Review testing strategy with collocated/remote teams and follow SDLC lifecycle to ensure testing is completed as per Radius Policies, SOPs and industry best practices

Overview:

A great team of engineers are transforming our systems to support huge growth in the scale and complexity of our business. As part of the ERP Applications team, you will focus on improving integrations between enterprise application systems through quality assurance tasks and test automation.

• Provide QA leadership for speci?c projects and initiatives.
• Develop and execute automated tests.
• Create testing strategies and formulate plans to increase the maturity of our QA practices.
• Perform some manual testing and code review inspections.
• Investigate test failures or other system anomalies and characterize possible root causes.
• Evaluate release quality and advise on go/no-go decisions.
• Analyze user stories and business process requirements to estimate quality risks.
• Clarify and improve user story descriptions and acceptance criteria, and occasionally create new stories.

• Experience using enterprise integration / middleware platforms such as Boomi, BizTalk, Mulesoft, SAP PI/PO, SAP CPI, Infomatica, Jitterbit, Workato, or TIBCO, and su?cient technical acumen to navigate through their artifacts to analyze implemented system logic and behavior.
• Exposure to typical enterprise business processes for a company that sells physical products - for example, familiarity with at least one of the following business functions: sales, logistics, purchasing, accounting, or supply chain.
• An ability to write moderately-complex SQL queries
• Experience working in a software development or technical quality assurance role over several years that utilizes programming skills in a contemporary object-oriented language.
• A demonstrable history of self-motivation and a bias towards taking action and getting things done.
• Solid competency with test automation using code- and UI-based testing frameworks and tools.
• Technical experience in testing cross-system integrations that utilize XML or JSON, and APIs.
• Preferred Quali?cations
• Familiarity with: event-based message bus architectures, Java, C#, .NET, Dell Boomi, Solace, SOA, Javascript, EDI, FTP, software security, object-oriented design patterns, microservices, SOAP/REST, and basic networking concepts.
• A familiarity with industry standard quality frameworks and an ability to apply such concepts to longer term software improvement strategies.
• Capabilities to analyze data using a range of statistical techniques and optimization algorithms.
• Confidence to advocate for quality with colleagues and stakeholders.
• Familiarity with multi-tier system architectures and source control principles.
• Experience manipulating data using a range of spreadsheet functions

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

Send Your Resume

Overview:

Our client is a large global manufacturing company in the Boston area. They need a senior level Project/Program Manager to come in and managed a re-implementation of their Salesforce Marketing Cloud. There is a heavy integration and data flow component in this role along with manage their systems integrator who is driving the technical aspects of the project.

• Provide Project Management oversight and leadership around the re-implementation of the Salesforce Marketing Cloud system.
• Responsible for managing the vendor/Systems Integrator and all aspects of the project.
• Responsible for planning around workflow, working on change management, and stakeholder management and communication.
• Communicate and advice key leadership on project updates and status reports.
• Responsible for driving integration plans, data flow, website integration

Overview:

Our client, a growing Life Sciences client kicking off a couple of SAP related projects within their Finance organization. We are looking for a Project Manager (Project Coordinator) to manage these projects. These are concurrent IT projects/enhancements in the Finance function.

• Implementing SAP Investment Management module
• Integration of SAP with planning system Planful
• SAP Accruals management
• SAP Training roll-out
• Bank integrations

Overview:

• 10+ years proven Project Management experience.
• Experience managing projects in an Agile methodology
• Experience supporting Data/BI/EDW and Analytics projects.
• Experience working in mid-sized businesses ideal
• Experience managing executive reporting and project status/schedule.
• Experience PMing product and item data programs
• Managing vendors development onshore and offshore.
• Experience project managing multiple groups across the globe.
• PMP preferred

Overview:

• Provide functional leadership around the implementation of the Transportation Management (Basic Shipping) module on S/4HANA.
• Responsible for configuration and implementation.
• Responsible for planning around workflow, working closely with change management team, and stakeholders.
• Help guide and advice key leadership on proper use of the system and opportunities to scale the system as the business grows.
• Responsible for driving integration plan

Overview:

• 10+ years SAP implementation experience as a PM
• Experience supporting complex global SAP programs
• Experience managing SAP system integrator
• Regulated industry experience for CSV project planning
• Mid-sized company implementation experience
• Some familiarity with ASAP implementation methodology

Overview:

• 10+ years of overall CSV experience
• Experience leading others within Validation and GmP documentation
• Must have prior experience documenting policies and procedures for an IT organization in a validated environment
• Must have strong experience creating documentation and validation plans in a GcP/GxP environment
• Previous Lead experience and a Clinical background is preferred

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

Overview:

• Define and Lead the execution and delivery of Clinical Operations and DCT initiatives.
• Coordinate and participate in requirement gathering and definition (Business Analysis)
• Establish and manage project timelines
• Ensure project goals and means meet business objectives and deliver value in a timely fashion
• Work collaboratively across the organization to gain alignment on project objectives and deliverables
• Engage with Computer Systems Validation lead to support appropriate validation activities
• Report on project progress and status

• 7+ years' experience in digital project management in a GxP environment
• Proven experience in DCT and Clinical Operations (CTMS) systems and processes in an on-shore/off-shore model
• You have a working knowledge of Decentralized Clinical Trials
• You have a tangible track record in using Agile approaches in a regulated environment
• As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of SaaS technology in a GxP environment and practical understanding of data integrity requirements.
• You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward.
• You don't hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity and lead a team effectively
• You put team before tasks by collaborating actively with all team members and supporting them.
• Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.

Overview: 

• Create and manage the project plan, manage timelines, business impact, vendors & integrator, stakeholder communication and expectations, budgets, resource allocation, etc…
• Must have prior experience with large scale integration projects including managing business impact, technical integrations, and business process integrations.
• This will be a large scale, highly visible, global project. So this person must have proven experience managing big mission critical projects on a global scale.
• Must have experience managing large scale integration projects with Oracle and Salesforce.
• The ideal candidate will have experience managing Quality systems projects in a global Manufacturing environment

Job Type: Contract (1028)

Overview:

Our client is embarking on a large-scale multi-year project to build out a RESTful API layer on AWS that will tie together their core SAP with a new shipping process and vendor. They asked us to find a senior level Architect who can guide them through the design phase and scoping out of this project. Qualifications: Extensive experience architecting/designing, project scoping, and building out large scale global API/AWS projects Must have a strong consultative background. This architect/design and project scope must be built and presented to executive steering committee in a polished and articulate way. Experience building RESTful services pulling data from ERP (ideally SAP, but any ERP is okay). Strong AWS background is necessary Any experience with Warehouse Management Systems, Transportation Management Systems, and Warehousing is a big plus, but not necessary. All data will be pulled from these systems and will flow into the middle layer (AWS).

Overview:

• Queue management and incident ticket triage of the ServiceNow queue
• Process Request/Tasks for Teams office phone number onboarding provisioning & offboarding deprovisioning
• Provision and configure Poly CCX 400/600 and Trio C60 phones for Administrators, Executives and VIP’s, Common Ares and Conference Rooms
• Troubleshoot Teams client and audio issues/quality, headsets, & call history
• Troubleshoot all Audio/Video equipment problems, coordinating resolution efforts with outside vendors as appropriate
• Perform remote firmware and software updates on Poly Phones (34 installed quickly growing to 300+) and Microsoft Teams Rooms systems (11 installed in Andover Boardroom, Austin & Broomfield)
• Perform preventative maintenance on AV equipment and consoles (restarts and log review)
• Microsoft Teams Administration support
• Monitoring and alerts from UC monitoring tools for device health & status (Crestron XIO & Office 365 Teams Admin)
• UCaaS Program: Perform assigned tasks to handle prerequisites of office moves and bulk voice migrations
• Testing of new processes, products and features as needed
• Develop written training materials: Tabletop instructions, How-To documents, Knowledge Base, FAQ’s, etc

Job Type (Contact 1038)