The Systems Engineer will be responsible for managing software deployments in a multi-site SCCM 2007 R2 or SCCM 2012 environments. The candidate must pose a superior knowledge as well as be able to demonstrate their technical proficiency in Microsoft Systems Center Configuration Manager (SCCM) 2007 or 2012 with experience in managing medium to large environments. The candidate must have a solid understanding of standard client/server, networking, and Internet fundamentals. The candidate should be able to troubleshoot all aspects of SCCM effectively and understand the product flow patch management, software distribution and logging in detail. Applicants should also have similar skills in Active Directory Services. Well versed in GPO’s and GPP’s.
• Strong knowledge and demonstrated technical proficiency in Microsoft System Center Configuration Manager (SCCM) 2007 and 2012
• Experience with Microsoft SCCM Task Sequences
• Experience in managing medium to large environments
• Solid working knowledge of Windows registry, file and folder security, local/domain user security, GPOs, and operating system troubleshooting
• Solid understanding of standard client/server, networking and internet technologies
• Expert working knowledge of the Windows Operating System, including but not limited to Windows XP, 7, and 8, Windows Server 2003 and 2008 R2, and ability to create zero touch deployments
• Experience with security, local and group policy, and various scripting languages including VB Scripting and batch scripting
• Working knowledge of ITIL, Change Management, Problem Management, Incident Management
• Able to effectively manage time and prioritize projects in order to meet established deadlines.
• Able to work and communicate effectively with all levels of co-workers and customers
• Must be a self-starter and have the ability to work independently or as part of a team
• Good interpersonal, written and oral communication skills
• Shares knowledge readily
• Ability to work independently on multiple projects
• Ability to research, design, and implement technical solutions to completion
• Ability to travel to various locations in the US
The Senior Business Intelligence Analyst will be responsible for gathering and refining Business Intelligence requirements associated with the clients IVSM system. This individual should have experience analyzing business processes and corresponding information needs. The analyst will interview users in order establish reporting needs, define key performance indicators and their attributes, develop data requirements, document the BI project scope, and establish user acceptance criteria. He/she will also develop functional requirements documents and design BI reports.
The Analyst will:
• Assist the BI staff in the development and analysis of Business Requirements Documents
• Help identify, assess, and document potential data sources and flows, and analyze existing Enterprise Data Warehouse structures to determine relevance to the needs of the IVSM program
• Participate in generating high level solution concepts in consultation with BI Solutions Architects and Development teams
• Write Functional Requirements Documents, participate in document reviews with business users and Development teams
• Document user acceptance test plans
• Design reports for business users
• Work cooperatively with BI Solutions Architects and developers during the development life cycle to ensure that business requirements guide the development life cycle
Requirements and General Skills:
• Strong interpersonal skills
• Ability to interpret, analyze and solve business problems with information technology solutions
• Strong analytical and quantitative problem solving skills
• Excellent verbal and written communication skills
• Ability to advocate for the needs identified in conjunction with business partners
• Experience with a subscription based business highly desirable
• Knowledge of data warehouse architectures and processes
• Experience authoring technical documents such as business requirements, functional requirements, database design representations, data and systems flow diagrams
• Understanding of the features and capabilities of one more DBMS’s commonly used in data warehousing such as Oracle, Teradata, SQL Server
• Proven record of participating in the delivery of new and enhanced to business intelligence capabilities
• Expertise developing and applying relational and dimensional data models
• Understanding of ETL architectures and experience deploying ETL solutions in a data warehousing environment
• Ability to conceptualize and communicate reporting strategies that address a wide range of information needs
• Development experience with at least one business intelligence tool such as Microstrategy, Cognos, or Business Objects
This position is responsible for functional and process requirements for projects, enhancements and systems support. This includes all phases of System Development Lifecycle: initial idea development, requirements capture, process design, application development, testing and implementation. This position will require the individual to develop a good understanding of the business functions and processes, and use this knowledge to be proactive in seeking to produce a lean and optimized design.
• Proficient in managing ADDM, CMDB, and integrations to the Atrium CMDB (BMC Certification preferred)
• Excellent knowledge of ADDM dependency mapping process and ability to work with Enterprise Architecture team & application owners to gather required information
• Strong organizational skills, with the ability to work with multiple groups performing application mapping
• Exceptional communications and interpersonal skills both verbal and written
• Database skills with a good understanding of database design
• Knowledge on Windows, Linux and AIX
• Knowledge of zOS helpful
• ITIL knowledge and experience required. ITIL Foundation Certification preferred
Role / Responsibilities:
– Serve as lead technical resource to deliver mobile applications and solutions in collaboration with our business and technology partners.
Bachelor’s Degree required. Bachelor’s Degree in Computer Science is preferred.
• Skills / Experience:
– 4+ years experience developing iOS enterprise apps.
– Strong knowledge of iOS development, Xcode and Objective C.
– Experience with Android, Hybrid and HTML5 development.
– Demonstrated experience in Agile and waterfall development.
– Prior experience in management of offshore development teams.
– Strong knowledge of RESTful web services.
– Evaluate new technologies and work with the ECCM Solution Architect and Enterprise Architecture to develop new standards and document solutions.
– Work with Mobile deployment lead to onboard new and incremental mobile apps to our various internal and external app stores.
– Perform code reviews and ensure mobile development standards are enforced.
– Excellent written and verbal communication skills.
– Familiarity with submission of apps to the Apple and Google Play Stores.
– Experience with Cloud technologies a plus.
BA/BS or Higher in analytical disciplines.
SAS Experience in Pharmaceutical or equivalent: = 7 years. Oncology experience required.
Experience with applying censoring rules and deriving PFS, OS and other time to event variables needed.
Have good knowledge of statistical terminology, clinical data structure , clinical tests, medical terminology, regulatory standards and protocol designs.
Strong SAS programming / Macros development / SAS graphs skills.
Demonstrated proficiency in using SAS to produce derived analysis datasets and produce tables, figures, and listings (TFLs).
Provided programming support on NDAs, sNDAs, ISS, ISE and post-submission activities.
Ensure the consistency and adherence to standards within the project.
Convert, check and integrate multiple sources of incoming data into the creation of analysis datasets.
Perform ad hoc flexible and rapid programming to address questions that arise from planned analyses and results.
Performing programming validation to ensure the quality of analysis datasets and programming outputs.
Perform most job functions independently.
Able to address challenging requests from other functional areas.
Demonstrated ability to work in a team environment with clinical team members.
Good interpersonal, communication, writing and organizational skills.
• Responsible for Lead Data Management activities (study start up to database lock) for Phase 1 Oncology studies
– Overseeing all CRO management including managing CRO deliverables and relationships at the study level
– Overseeing development and review on all CDM study-related documents (i.e. CRFs, Data Management Plan, CRF completion guidelines, etc.)
– Performing in-house monitoring of data entry into EDC Clinical database, data review and reconciliation of outstanding queries
– Assisting in the design of Data Documentation (paper prototype of CRF) in compliance with protocol assuring consistency, clarity, and simplicity
– Reviewing and contribute to the preparation of protocols from the DM perspective
– Responsible for receiving accurate data transfers and communicating with the CRO all discrepancies that are found
– Responsible for CDM process decisions with the CRO (i.e. moving study database into production environment, requesting/authorizing database modifications, database lock sign-off, etc.)
– Performing manual data review, generate data queries and issue the data queries to the site
– Updating the database per Data Clarification Forms, Data Resolution Forms, Self Evident Corrections, as well as Data Handling Conventions
– Reconcile coding and clinical operations data issues
– Generating weekly study data report
– Performing external data reconciliation (ECG)
– Performing Quality Control activities by reconciling quality control findings
1) Responsible for transitioning electronic Change Control Files from an existing module (GXP) to the new Global Change Management (GCM) module within eQRMS (EtQ based system). The transition process will be governed by a protocol and the incumbent would work within the instructions defined in the protocol to execute the transition process.
2) Support the Global QMS team in the management, processing and maintenance of the CAPA, Deviation, Product Quality Complaint and Change Management systems. This includes daily support activities such as:
– metric production (utilizing excel, powerpoint)
– report generation
– document management activities
– miscellaneous training related actions.
3) Support the implementation of new and/or enhancements to the existing electronic quality system platforms. Assists in the implementation of new practices/systems in keeping with constantly changing/emerging FDA/industry requirements.
BS in the Sciences or Pharmaceutical related field is preferred with 2-4 years relevant QA experience.
Alternatively, 2 years of higher education with 4 years relevant QA experience may be acceptable.
Good computer skills and working knowledge of common business software
Good knowledge of GMP requirements
Excellent organizational skills
Excellent problem-solving, verbal and written communication skills
Must have strong interpersonal and communication skills, be a team player
Ability to work accurately under tight deadlines.
Must be able to plan and manage multiple priorities.
Our client is in need of a Telecommunication Network Administrator. This person will be responsible to organize and coordinates the activities associated with installation, deployment, and upgrade of software, hardware and network facilities. Also, identifies, researches, and resolves technical problems proactively establishing root cause and mitigation recommendations to prevent further issues. • Experience and expert level in all fields listed below: o Cisco, Nortel and Juniper equipment configuration, support & management o WAN / LAN architecture and VOIP network architecture o Networking (E.G. DNS, DHCP, QIP) o Deployment of network equipment in large Global Corporate environments • Cisco certification required CCNA, CCNP, etc. • Ability to use network diagnostic equipment to evaluate and diagnose potential network related issues • Excellent communication skills, written and oral • Experience working with remote teams • Self-directed with the ability to develop action plans, reports, status, and presentation material • Bi-lingual language skills helpful, but not required
• Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised
• Note = For Contract positions functionality may be narrowly defined based on business needs
AE CASE MANAGEMENT
• Execute receipt of Drug Safety phone calls and complete telephone AE form
• Create phone call communication logs in ARISg
• Support the triage of cases conducted by Senior Specialist as needed
• Execute QC on key fields of serious cases
• Create key fields updates in ARISg based on QC, as needed
• Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
• Create narratives as needed
• Review & update auto-narrative as needed
• Create draft company comments for serious cases
• Develop event rankings
• Create dechallenge / rechallenge determinations
• Develop follow-up needs for AE reports
• Create targeted follow-up letters
• Review and update generated follow-up letters as appropriate
• Authorize (approve) non-serious cases
• Create major modifications following Medical Review
• Support the identification of corrections and creation of updates in ARISg following medical review
PHARMACOVIGILANCE (APPROVED PRODUCTS)
• Update AE reports within safety database to support line listings
COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT
Preparation for Regulatory Inspection
• Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
INTERNAL GLOBALSAFETY DEPARTMENT DEVELOPMENT
• Participate in team meetings within the drug safety department
• Contribute to the orientation and training of staff as needed.
The candidate must be able to produce a high volume of high quality cases within a busy Drug Safety work environment. Healthcare professionals are preferred.
Responsibilities will include, but are not limited to:
1. Functional proficiencies:
• Reviews synopsis/protocol and attends Synopsis Review Committee (SRC) meetings
• Leads DM study start-up and maintenance activities
• CRF design/edit check specifications//external vendor specifications, CRF completion guidelines, (CCGs), coding, IVRS, etc.
• Leads development of site/investigator training materials and present at Investigator Meetings
• Leads Celgene team with User Acceptance Testing as applicable
• Leads SAE reconciliation
• Demonstrates ability to analyze data, share trends/observations with team members around results and relevant metrics
• Leads data review and query management
• Prepares the Data Management Plan and essential documentation
• Adheres to data standards and proper data validation processes
• Performs reconciliation of external data
• Leads database lock activities: inclusive of final SAE reconciliation/final data review, study decommission, etc.
• Lead/Participate in regular team meetings and provide input when appropriate
• Core study team member and primary contact for data management
• Provide input and assist in review/adherence to project timelines
2. CRO/vendor oversight:
• Provides oversight of vendor activities to ensure quality and timely deliverables
• Participates in CRO/external vendor selection
• Review Statement of Work (SOW)/contracts
• Provides CRO oversight of the data management functional activities and monitor progress and deliverables
• Ensures training on Celgene SOPs, if applicable
3. Additional Activities:
• Participates in writing/reviewing of functional SOPs/Working Procedures/Guidance Documents
• Leads/participates in department initiatives
• Ensures departmental companion groups (Programming, Coding, CDSI, etc.) are consulted appropriately on study decisions
• Trains Data Managers on Celgene standards and processes
• Liaise with cross-functional teams to provide data management deliverables to health agencies
• Participates in submission activities, if applicable
• Plans and executes own area of responsibilities through predefined standards and objectives
• Work is completed under minimal supervision; routine work may require little to no instruction
• Shows solid interpersonal skills and understanding of all project team functions to obtain necessary information from other project team members
• Working knowledge of EDC databases, preferably Medidata RAVE. Knowledge of J-Review or other reporting tool and basic understanding of SDTM and CDISC
• Strong written and oral communication skills
• Ability to work in a study team environment
• Intermediate knowledge of therapeutic area(s)
• Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
Please note that the manager checked “yes” for travel and indicated 10%.