WeStaffIT, Inc.

"Your IT Staffing Solutions Partner"

Project Manager/Business Systems Analyst

POSITION SUMMARY

This is a tremendous opportunity for someone looking to leverage their project management accumen along with their honed requirements gathering and business analyst skills.  This role will involve project planning, execution, and implementation of small to medium-sized technology-enabled solutions to internal business units. The Project Manager/Business Systems Analyst (PM/BSA) will lead the formulation of and definition of systems scope based on both business user needs and an understanding of the business systems and industry as it relates to those projects.

 

WHAT YOU’LL DO

 

  • Provide project leadership using the system development life cycle for small to medium-sized projects, especially cross-departmental projects, including meeting facilitation.
  • Perform QA testing, including planning and executing unit, integration, and acceptance testing, in support of timely, quality project implementation
  • Develop Functional and Design Specifications, including use cases, data flows in support of timely, quality project implementation.
  • Perform analysis in support of timely, quality project implementation.
  • Provide end-user training for implemented systems/processes along with accompanying training manuals or user guides.
  • Partner with senior PM/Business Systems Analyst on more complex projects.
  • Performs other related duties and special projects as assigned.

 

WHAT YOU’LL BRING

  • A degree from a four-year college (e. g., BS) or equivalent work experience.
  • Minimum 3 years of experience as a Business Systems Analyst and/or an IT Project Manager in a healthcare environment.
    • Experience using MicroStrategy BI tool preferred.
  • Prior experience at a healthcare organization, particularly at a managed health plan.
  • Prior experience in IT infrastructure and security.
  • Excellent communication skills and a high degree of adaptability.
  • A passion to work in a dynamic, highly collaborative environment.

 

 

Sr. Clinical Data Manager (Oncology)

THIS ROLE IS CONTRACT, EITHER W2 OR C2C

NO REMOTE OR TELECOMMUTE. ALL WORK IS ONSITE AT CLIENT’S OFFICES IN EITHER SOUTH SAN FRANCISCO OR WEST LA

Our Biotechnology client has an immediate need for a Clinical Data Manager on a long term contract basis to lead studies in Oncology areas. You will be responsible for coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents, coordinates database live and close out activities with the CRO, provides guidance to CRO to manage query flow and implements quality control plan. The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance.

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. Able to perform a thoroughly detailed review of data requirements.
Interact with CRAs, programmers, study managers and statisticians.
Develop data edit check specifications and run data listings as
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 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
Assist with the training of new employees and/or contractors

Requirements:
BA/BS, preferably in the scientific/healthcare field.
At least five – seven years experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
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 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.

EDI Manager (managed healthcare)

ABOUT YOU

 

You will be responsible for leading the daily activities and  the strategic direction of the EDI team of Analysts and Programmers in this key leadership role.  The team plays a pivotal role in helping our business departments, Trading Partners, contracted networks, hospitals and providers’ ASC X12 transactions be compliant with HIPAA and state/federal regulations.  Using your solid knowledge of EDI, you’ll help implement and manage successful EDI solutions that will strengthen our core and further scale our operations.

 

You’ll be a key liaison between internal business units for all EDI / File Gateway requirements, particularly eligibility, providers, claims and encounters. And as a key stakeholder and business leader, your commitment to continuous improvement efforts by developing business processes and strategic leadership, will help us best serve our providers and members.

 

WHAT YOU’LL DO:

 

  • Day to day team leadership and EDI resource development
  • Liaison between key internal and external stakeholders and the EDI team
  • Manage prioritization, assignment and maintenance of EDI processes and applications
  • Responsible for the design and architecture of scalable and robust EDI solutions
  • Create and integrate maps and processes within EDI systems
  • Participate in and provide analytical support for the design and implementation of new systems
  • Serve as subject matter expert for implementation and integration of EDI transaction maps.
  • Develop global processes related to EDI services and support
  • Oversee operational support for EDI platform and applications, including issue resolution
  • Provide ongoing internal customer support for EDI product questions and problems
  • Ensure development, documentation, and communication of progress reports pertaining to new EDI transaction maps, business edits and new trading partner onboarding
  • Manage EDI-related business support responsibilities, which include production monitoring, file maintenance, ad hoc reporting, and consultation with internal and external users
  • Perform team administrative duties including status reporting, team development, self/peer/project assessments
  • Develop analytical skills and increases applications knowledge within the team and lead efforts to develop department core competencies, execute cross training, and implement succession plan.
  • Carry out personnel management activities including performance management and career development.
  • Mentor, coach, and guide staff under EDI Management team.
  • Ensure appropriate level of support for the ongoing performance of EDI processes and applications.
  • Maintain a leadership role in setting service direction and ensures standards and policies are maintained and compatible with SFHP standards
  • Collaborate with all ITS Management peers to improve departmental and organizational performance by developing benchmark measures to evaluate productivity and service quality.

 

WHAT YOU WILL BRING

 

Proficient knowledge in:

  • BizTalk
  • EDI application mapping techniques
  • Edifecs or ClarEDI
  • HIPAA ASC X12 transaction sets for healthcare (834, 837, 277, 835, 997/9, 270/1, 276/7, Proprietary Auths)
  • HIPAA 5010
  • HIPAA security policies and procedures.
  • Systems implementation
  • QNXT (desirable)

Proven skills in:

  • Leadership and project management, including managing/developing staff, promoting teamwork and encouraging innovative ideas.
  • Working with business stakeholders to define application strategies, roadmaps and funding requests.
  • Strategic thinking and planning with operational execution excellence.

 

Experience

  • BS or equivalent combination of education and work experience
  • 8 + years of IT and business work experience with a broad range of exposure to various technical environments and business units, particularly claims.
  • 5+ years of progressive experience with EDI, familiarity with .net and SQL
  • 3+ years of managerial experience in EDI strategic planning and daily operations.
  • 5+ years of proven experience in SDLC (Waterfall, Agile) creation, implementation and enforcement.

 

LOCAL CANDIDATES ONLY PLEASE

US CITIZENS AND GREEN CARD HOLDERS ONLY PLEASE