Consulting Opportunities

The Role:

• Partner with clinical operations, data management, biostats, clinical supplies organization, medical affairs, regulatory and safety to execute on our leading edge digital and analytics strategy to support accelerated drug development.
• Business analysis and system support for clinical operations, drug supply, patient recruitment, biosample management and regulatory business units in a high growth fast-paced environment.
• Lead user centered design workshops for the collection and refinement of user requirements
• Collaborate with data engineering, informatics and data science team to develop modern analytics applications
• Engage with digital integration engineering team, business and quality systems teams to implement cross-functional integrations and support our digital integrated landscape
• Prototype analytics applications to support data stories and support user testing activities as part of application release cycle
• Author requirement documents: epic, user stories and associated functional and design documents
• Author and manage testing artifacts to support product releases
• Support product owners in product backlog grooming and releases definition
• Organize sustainable and scalable support processes to delight your customers

• Fundamentally you are a business systems analyst who enjoys interacting with your end users and can drive products definition and execution in a fast moving digital organization. You understand and practice lean and user centered design methodology. You are passionate about drug development and bringing new medicines to patients.
• At least 5 years’ experience in the definition, design, implementation and support of analytics solutions across the following Clinical Systems
  • Legacy CTMS (Impact, Siebel)
  • IRT/IWRS
  • EDC
• Veeva Clinical Vault (CTMS, eTMF, SSU etc..)
• Clinical data warehouse
• Clinical operations data warehouse
• Site engagement portals
• Decentralized trials platforms
• You have a proven experience with external vendor integration (CRO, central labs, imaging labs etc..) and vendor technology management
• You exhibit deep understanding of clinical development operational metrics and key performance indicators.
• Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR)
• You have a basic understanding of advanced analytics concepts (AI/ML) and the application if data science to clinical data
• Tangible track record in using Agile approaches for product development
• As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.
• You have a working knowledge of clinical operations, clinical data management, regulatory and safety business processes in a drug development context
• 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 the team. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity 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:

• 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: 

• Working under the supervision of the Data & Analytics manager, partner with the business and data analysts to design, develop and maintain custom and ETL programs/ procedures to support a new Enterprise Data Warehouse.
• Gather and identify system requirements for new solutions through collaboration with data analysts, business users and other developers.
• Ability to develop and maintain programs to extract, transform and load structured data from disparate systems both on premise and in the cloud.
• As part of a cross-functional agile team, design system data models, data integrations/ETL and process automation solutions.
• Work closely with various technical resources to determine best practices and implement non-functional requirements such as exception/error handling, performance optimization and source code promotion/migration.
• Use various SQL tools/ scripts to diagnose data issues, identify fixes and implement solutions.
• Support ongoing changes to existing TSQL programs/ applications and data migrations (ETL) and be available to support system deployments/ rollouts.
• Be a self-starter with solid interpersonal skills - projecting a very positive customer-service-oriented attitude.
• Adhere to the processes and policies defined by UniFirst.

• BS or MS in Information Systems, Computer Science, Engineering, or equivalent.
• 5 years’ experience as a ETL developer or related role in supporting data warehouse projects.
• Proficiency in TSQL development in a data warehousing context
• Proficiency in SSIS or similar data migration/ ETL tools
• Proficiency working with large data sets
• Experience with fact and dimension data models required
• Solid relational database experience required, and DBA knowledge preferred
• Experience with agile project management techniques preferred
• Experience with other data capabilities/concepts such as master data management, data integration, business intelligence and data quality tools are preferred.
• Ability to work alone or with other members of a team
• Impeccable customer service and interpersonal skills and excellent written and verbal communications skills mandatory.
• Experience in customer management, contracts, product, pricing, invoicing and commissions preferred
• Ability to provide solid solutions to current and anticipated business challenge

Overview:

• Working under the supervision of the Data Management and Analytics Manager, partner with key business users and stakeholders to define data migration requirements, resolve data issues and ensure proper data quality and testing of deliverables.
• Ensure that the team has an adequate amount of prioritized work ready to be groomed as sprint candidates
• Prioritize product feature backlog and define acceptance criteria for the product.
• Provide backlog management, iteration planning, and elaboration of the user stories.
• Lead the planning of product release plans and set expectations for delivery of new functionalities.
• Working with developers to assure specifications are understood and followed
• Supporting quality assurance and user acceptance testing

• BS or MS in Information Systems, Computer Science, Engineering, or equivalent.
• 5 years’ experience as a Product Owner in a data management or related role in supporting large data projects
• Strong experience with ERP implementations, with at least the following capabilities:
• Customer Relationship Management, Order to Cash, Inventory and Material Management, Incentive Compensation.
• Experience with data governance, master data management, data warehouse and business intelligence
• Comfortable driving teams and management to decisions; willing to push-back for information and answers. Excellent verbal, written, and interpersonal communication skills
• Strong ability to communicate effectively and present data solutions to team partners, stakeholders and executive leadership.
• Be a self-starter with solid interpersonal skills - projecting a very positive partnership.
• Ability to understand and work with large quantities of data to identify trends, errors and gaps
• Ability to multi-task and manage concurrent projects in various stages of development
• Adept at adjusting to changing circumstances quickly and professionally, the ability to make quick decisions when clarification or modification is necessary.
• Impeccable customer service and interpersonal skills and excellent written and verbal communications skills mandatory.
• Proficient in SQL for database query, troubleshooting and reporting
• Experience with ERP systems preferred

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:

• 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:

One of our large pharmaceutical clients is harmonizing their global LMS platform into one common application globally. They currently have six different platforms from many company acquisitions. They will need a formal PM to help manage and drive the implementation globally. This LMS will be validated so experience planning and scoping CSV into the project plan will be required.

• 7+ years experience project managing within Life Sciences
• Experience driving global initiatives
• Experience reporting into a PMO
• PMP and or CSM certifications preferred
• Experience with LMS or document management prefered

Overview:

• Must have a proven track record implementing Veeva CRM within the life sciences industry.
• Must have strong communication and organizational skills. This role is a heavy business facing role and requires a lot of vendor management and stakeholder communication.
• Ability to work independently and as part of a team on projects. This role will have a great deal of independence but expectations are high and timelines are critical.

Job Type: Contract (1025)

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: 

• 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 going to be kicking off a big integration project due to an acquisition they made. We are working with the CIO to help find a Project/Program Manager to come on for at least 6 months to manage this project from a technology and business perspective.

• 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 due to M&A activity.
• 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.

Job Type: Contract (1019)

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)