WeStaffIT, Inc.

"Your IT Staffing Solutions Partner"

Clinical Data Manager

Our Biotechnology client has an immediate need for a Clinical Data Manager to lead studies in the Sleep Medicine and Hematology/Oncology areas. You will be an active member of a multi-disciplinary team to plan and execute Data Management tasks required for phase 1-4 studies. In addition, you will be a part of an R&D Operations group that intends to implement the most up-to-date methods of data-driven trial management and hence has a key role in the organization.

Responsibilities:

  • Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
  • Able to support several clinical studies with minimal guidance
  • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
  • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. Able to perform a thoroughly detailed review of eCRF data requirements.
  • Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
  • Develop data edit check specifications and run data listings as required
  • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
  • Develop the Data Management Plan for a clinical study.
  • Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans,
  • Statistical analysis plans and vendor specifications
  • Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
  • Perform reconciliation of header data from external data sources against the clinical database
  • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
  • Assist in database upgrades/migrations including performing User Acceptance Testing
  • Able to maintain study workbooks and data management files
  • Perform database lock and freeze activities per company SOPs
  • Participate in regular team meetings and provide input when appropriate
  • Provide input into the development of data management SOPs, Work Instructions, and process documents
  • Contribute to a professional working environment including the application of Code of Business Conduct and Ethics
    Assist with the training of new employees and/or contractors

Requirements:

  • BA/BS, preferably in the scientific/healthcare field.
  • At least two years experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
  • Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
  • Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are desirable.
  • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.

IT Operations II – 2016

Examples of Key Duties: (Duties are illustrative and not inclusive and may vary with individual assignment.)

  • Installs, configures and upgrades operating systems and software, using standard business and administrative packages; may modify specific applications for use in operational departments.
  • Install, configure and administer systems or applications used for Hospital or Office use and support.
  • Develop and maintain installation and configuration procedures and documentation.
  • Administer, update and maintain the VMWare environment
  • Research new products and technologies to improve IT Services. ¬ Work with vendors to develop/maintain standards of performance and up-time.
  • Contribute to and maintain system standards.
  • Develop, modify, maintain, improve, and troubleshoot existing systems. ¬
  • Research and recommend innovative, and where possible automated approaches for system administration tasks.
  • Identify approaches that leverage our resources and provide economies of scale.
  • Perform daily system monitoring, verifying the integrity and availability of all hardware, server resources, systems and key processes, reviewing system and application logs, and verifying completion of scheduled jobs such as backups.
  • Provide all levels of support per request from various departments. Investigate and troubleshoot issues.
  • Repair and recover from hardware or software failures. Coordinate and communicate with impacted departments or users.
  • Apply OS and application patches and upgrades on a regular basis, and upgrade administrative tools and utilities. Configure/add new services as necessary.
  • Perform ongoing performance tuning, hardware upgrades, and resource optimization as required. Configure CPU, memory, and disk partitions as required.
  • Use system administration tools for application distribution, asset management, and desktop support as needed.
  • Provide assistance to end users, optimizing systems operations, ensuring compliance with Licensing agreements, security requirements and system accuracy.
  • Ability to work in a fast paced environment that requires one to be a self-starter, customer focused and willing to explore “best practices” in the industry.

Qualifications:

  • B.S. in computer science or related field and/or experience in lieu of degree
  • Two to three years of similar experience
  • Experience in Microsoft Active Directory, VShere, HyperV and Backup software
  • Windows Server (2008/2012) security skills, server, desktop and network hardware configurations
  • Current experience in Infrastructure and Enterprise environments
  • Experienced in executing sound judgment to plan and execute goals
  • Analytical/prioritization and troubleshooting skills
  • Excellent verbal, written, interpersonal and organization skills
  • Manage multiple projects; both short and long term
  • Ability to effectively work and communicate with employees ranging from general staff to senior management.
  • Ability to work independently, make good use of time and prioritize multiple tasks
  • Knowledge and experience in hardware/server maintenance
  • Must be able to travel when needed
  • Must have a valid driver’s license and a good driving record

Physical Requirements and Working Conditions:
Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer, stamina to maintain attention to detail despite interruptions, strength to lift and carry objects weighing up to 40 pounds; vision to read printed materials and a computer screen; and hearing and speech to communicate in person and over the telephone.

*Difference between I and II is years of experience and expertise

Senior Systems Analyst

Epson, a provider of best-in-class digital solutions and a world leader in the development of new technologies, is seeking a talented Senior Systems Analyst to support SAP Advanced Planning & Optimization (APO) business processes.

This is a great opportunity to work on the latest technology platforms and expand to industry valued Business Intelligence and other logistics or financial supply chain management solution areas.  It is also an opportunity for those professionals looking for career stability and growth within an organization.

  • Will be responsible for supporting SAP APO projects according to specifications and schedules while meeting quality requirements
  • Maintain an in-depth understanding of all Epson business processes and requirements as it relates to configuring SAP ECC 6.0 and its integration with the rest of the SAP components
  • Resolve day-to-day user system support issues related to system functionality, performance, efficiency, and availability of production systems within area of responsibility
  • Gathering, organizing, and documenting business user requirements
  • Participating in the research and evaluation of appropriate software products being considered for acquisition
  • Participating in the production of and approved project plan by drafting detailed task schedules for review
  • Performing in and contributing to application functional design and review
  • Day-to-day maintenance of production application systems
  • Developing functional documentation of IS and business needs
  • Participating in Disaster Recovery testing to help ensure business continuance

Requirements:

  • Have excellent interpersonal, listening, verbal and written communication skills
  • Enjoy working with a team while possessing a strong independent work ethic
  • 6-8+ years of SAP experience in the core module of specialization and 2-4 years of domain experience
  • Must have good knowledge of the SAP APO module and be able to design, configure and build solutions
  • Completion of an undergraduate program required (B.A. or B.S)
  • Have demonstrated experienced as a key contributor to multiple end-to-end SAP implementation projects
  • Have worked on projects using Accelerated SAP methodology for implementations
  • International project experience specifically in South America and working in multi-cultural teams is preferred;
    Bilingual skills (Spanish and/or Portuguese) preferred