HI,

Hope you are doing great!

This is Harry from Dynamic Enterprise Solutions. We have urgent requirement
with one of our client's, please review below job description and let me
know your interest

 

Position ID: DESAL00012456

Title: SAS  Clinical Program  Analyst

Location: Alameda, California

Duration: 12 Months+

Rate: $ 45-48/HR (max)

 

Locals Only (On-site work Required)

 

Position Summary from Legacy System

This field includes Main Responsibilities imported from Legacy System.

This position is responsible for implementation of data management
activities in support of clinical trials, including: design and maintenance
of clinical databases using Oracle Clinical or other major Clinical
database, SAS; review of data collection forms; generation of data tables,
listings and reports; establishment and documentation of data management
processes.  Designs, programs, installs and maintains quality databases for
the clinical studies. Provides technical support for assigned databases
responding to database and user problems. Determines causes and resolutions
of problems when they arise to ensure continued operations. Writes user
documentation, functional and technical specification documents. Ensures
data validation specifications are comprehensive, appropriate, and are
created according to the company procedures and requirements. Extracts
clinical study data from the databases and prepares data for statistical
analyses, develops programs to create data listings and summary tables,
provides programming support needed to analyze the data.

 

Additional Main Responsibilities from Legacy System

This field includes Main Responsibilities imported from Legacy System.

Ensure that database design is consistent with 21 CFR part 11.

Provide input to the development of case report forms, in conjunction with
Clinical Research and Clinical Data Specialists.

Annotate CRFs and develop study clinical databases using Oracle Clinical or
other clinical database.

In conjunction with Clinical Data Specialists, write study specific data
entry work instructions.

In conjunction with the Validation team, ensure databases are validated and
data entry training has been provided before the database is activated.

With Clinical Research staff and Clinical Data Specialists, contribute to
the development of data edit check rules.

Program edit checks and provide documentation of data validation checks.

Contribute to Data Management Plan to document study specific data
management activities that will ensure data integrity.

Participate in efforts to standardize, streamline and enhance DM processes,
write SOPs.

Generate data tables, listings, reports, and ad hoc queries from Oracle
Clinical and related databases using SAS or other software tools.

Maintain clinical databases according to change control procedures.

Oversee query generation and resolution and resolve issues with validation
rules.

Provide programming support to the CRAs as needed.

Act as a resource for database related questions.

Prepare and review reports clearly communicating results in a manner
suitable for both technical and nontechnical customers.

Support software requirements including development, maintenance and
validation of software for Clinical Affairs Group as required.

Provide general (statistical) software support to the Clinical Affairs Group
and other departments as required.

Collaborate with company wide groups as and when required.

Provide supervision to staff, including setting direction and goals,
performance reviews and development plans as and when required.

Must be able to tap into appropriate resources when specific expertise is
needed that cannot be achieved individually.

Support relevant training activities, presenting data and results in a
suitable format.

 

Accountability/Scope/Budget from Legacy System

This field includes Accountability/Scope/Budget information imported from
Legacy System.

Support of mission critical Clinical systems Completes given projects on
time, accountable for the project timelines  Clearly communicates with
management and peers   Assumes responsibility for completing individual and
team assignments and tasks         Reliable attendance is required for this
position  Individual contribution should make a measurable difference to the
department and the business.

Works on technical problems of moderate scope where analysis of the system
requires technical expertise.

Exercises judgment to achieve desirable end results.

May work on several technical problems of moderate scope where analysis
requires review of given parameters/systems and strong communication skills.

Exercises judgment within defined procedures and practices to determine
appropriate action.

Adjusts and correlates clinical data, analyzes results, and recognizes and
corrects system bugs.

Performs work using existing standards, methodologies and processes,
investigates alternatives.

Learns new software and supports it.

Understands and applies procedures, practices and department standards to
consistently produce error free results in a timely manner.

Develops project plans and ensures the dates are met.

Independently proposes and develops new programs to handle and analyze
clinical data.

Identifies and implements process improvements.

Aware of other business processes and related disciplines and how they
relate to each other.

Participates in projects as a Clinical programmer.

Makes decisions on the software and internal structure of the Clinical
Database.

Creates database development plans and follows the plan through a series of
related detailed steps to achieve the anticipated goal.

Completes project tasks within time and budget constraints.

Works under general supervision of Manager or Principal Programmer.

Work is reviewed for soundness of judgment and to determine if desired
results have been achieved.

Risks associated with tasks extend to impact on a major study timeline.

Programming expertise is recognized by peers, Clinical group and management.

Directs shortterm activities performed by vendors, or less experienced
peers.

Influences timelines of the studies.

Sells new processes/software solutions/programming practices to management
and peers.

Deals regularly with other members of the Clinical group and managers within
department and vendors.

Will represent database sub-group of DM group on projects or segments of
projects.

 

QUALIFICATIONS

Note: This job description is not to be considered an exhaustive statement
of duties, responsibilities or requirements and does not limit the
assignment of additional duties for this role.

 

Additional Qualifications from Legacy System

This field includes Qualifications imported from Legacy System.

Bachelors degree required.  Biostatistics, statistics, information science,
public health, or life science preferred.   Minimum of 3 years experience in
clinical research and database programming; prefer at least 1 year in device
or pharmaceutical clinical trials as a clinical programmer performing
mentioned above functions using SAS, Oracle Clinical or Clintrial
and/orACCESS  Experience building at least one major clinical database
Coordinates and monitors activities/projects  Able to set up, clearly
communicate and follow project plans  Participated in SOP, WI and other
guidelines design  Provides technical support to all the members of the team
Actively participates in activities (teamwork). and makes valued
contribution to multidisciplinary team projects.  Shares resources,
knowledge and accountability, leads others   Must have experience in using
SAS, word processor applications, spreadsheets and databases.  Must be
accurate and organised in work approach and have good attention to detail in
order to ensure that the programs developed meet requirements and are fit
for purpose.  Must have good oral communication skills to be able to provide
management and staff with feedback on performance and development needs and
report and present progress to Senior Management.  Must have good written
communication skills to be able to prepare appropriate reports, interpret
results and prepare effective summaries relative to the implications of
those results.

 

Position ID: DESAL00012655

Title: Network Technician - C

Location: Waukegan, IL

Duration: 9 Months+

Rate: $ 42/HR (max)

 

Locals Only (On-site work Required)

 

Responsibilities 

. Understand network infrastructure design best-practices that meet business
requirements. 

. Strong understanding of the OSI model and how it related to all network
equipment and network communications. 

. Manage and troubleshoot WAN routers - Strong experience with BGP, OSPF and
static routes. 

. Manage and troubleshoot Firewalls - Checkpoint experience desired. 

. Manage and troubleshoot network switches including Cisco and Extreme.
Strong understanding of layer 2 protocol including STP, LLDP, Port Channels
and UDLD. Extreme protocol EAPS, ELRP. 

. Manage and troubleshoot Wireless LAN Controllers and Access Points - Cisco
and Extreme. Experience troubleshooting wireless coverage issues desired. 

. Manage and troubleshoot network management and monitoring tools -
experience with Solarwinds and Logic monitor desired. 

. Has experience with network configuration backup, recovery, and disaster
planning. 

. Strong experience with log analysis to troubleshoot events as they are
related to a incident. Experience with Splunk is desired. 

. Experience with creating and maintaining all documentation as it relates
to processes and procedures for network configuration, mapping, processes,
service records, SLAs, and how to-dos. 

. Experience with formal change control process, standards, RCA and SLAs. 

. Provide service and support to a variety of end users by creating trouble
tickets, answer questions, and resolve problems. 

. Must be willing to perform duties periodically outside of normal business
hours. May be required to work-from-home as needed

 

Position ID: DESAL00013030

Title: Software Cyber security Engineer

Location: St. Paul, MN

Duration: 6 Months+

 

Locals Only (On-site work Required)

 

Responsibilities 

. Vulnerability testing 

. Cyber security background 

. Off the shelf software updating experience 

. System packaging technology 

. WICKS toolset installation 

. Bachelor's Degree in Engineering (Computer, Electrical, Computer Systems,
Systems, or Software), Computer Science, or related discipline 

. 1-3 years of cybersecurity engineering, software engineering design and
development, or systems administration experience 

. Experience in assessing and remediating cybersecurity vulnerabilities 

. Experience in assessment of Off the Shelf Software (OTS) 

. Demonstrated knowledge and experience working with C++, Python, Perl, or
Shell 

. Experience in Linux system administration on RHEL or similar distributions


. Previous experience working in a regulated industry such as automotive,
aerospace, healthcare, or defense 

. Excellent verbal and written communication skills, with ability to
communicate to all levels of the organization 

. Well versed in FDA Cybersecurity Guidance, GDPR, and NIST 

. Familiar with DISA STIG assessment and implementation for Linux and/or
Windows systems 

. Knowledge of secure programming practices 

. Experience in threat modeling and cybersecurity risk assessment 

. Cybersecurity certification such as CISSP, CSSLP, or similar 

. Knowledge of 62304 and other standards applicable to Class II and Class
III medical devices Phone screen followed by web ex Open to national search
Candidates will be working a blended, part time Contract position -possible
extension 

 

Top skills: 

Assessing and remediating software vulnerability's Software domain
experience 

Ability to do sub development work in the specific language in the req

 

Position ID: DYES00011360

Title: Project Manager Mainstream IV (DII3) - Information Security Risk
Management

Location: North Chicago, IL

Duration: 6 Months+ 

 

Locals Preferred

 

Primary Needs: 

.      Position will reside within the Information Security Risk Management
(ISRM) Team at Client, driving functional continuous improvement projects
aimed at improving strategic and operational capabilities, including
formulating long-term strategy & roadmaps. 

.      Experience in managing Information Security, Governance and
Compliance projects would be beneficial, as this Project Manager will lead a
variety of projects within the following 6 ISRM key workstreams aimed at
driving strategy: 

.         ISRM strategy to address risk 

.         Driving risk accountability 

.         Scaling ISRM capabilities 

.         Continuous improvement processes 

.         ISRM / IAI (Innovation/Architecture/Infrastructure) collaboration 

.         ISRM intake process improvement 

.      Must be a senior level project manager (12+ years of experience) with
a strategic mindset. Note: this position will require experience in managing
strategic projects/focused on strategy. Technical experience within ISRM
projects will be a lower priority for any PM applying. 

.      Will be expected to prepare and present executive level
presentations. 

.      Strong project management skillset, including proven ability to lead
and drive project success. 

.      Strong collaboration and communication skills given the high degrees
of business strategic impact, Senior Executive interactions, and project
complexities, accompanied by a medium degree of change. 

.      Will work with multiple internal Client teams & staff. 

.      Contract to run from candidate's start date through April 30, 2021.
(Extensions possible following proven performance.) 

.      Will execute and deliver in line with below expectations. 

Expectations: 

.      Develop, execute and manage project(s) within the defined scope. 

.      Lead all aspects of the project lifecycle, working with project
sponsors/key stakeholders, team members, and management to oversee all
phases of project completion. 

.      Build and manage project's work breakdown structure, milestones,
risks, issues, and deliverables within the constraints of human and
financial resources and changing priorities to ensure the successful
completion of the project. 

.      Ensure transparent reporting of project status, issues, risks, and
financials. 

.      The individual will rely on experience and judgment to plan and
accomplish goals. 

.      Performs a variety of tasks. 

.      May lead and direct the work of others. 

.      Be able to work under general supervision. 

.      A certain degree of creativity and latitude is required. 

Specific Responsibilities: 

.      Initiate and Plan Project: Works with business, ISRM and IT
management to establish and gain consensus on project goals, objectives,
financials and deliverables. 

.      Project Control: Assess the degree to which changes to scope, issues
and risks will affect the project, working with business and IT management
and sponsor to gain agreement for resolution. Measure performance to assure
the project is progressing as compared to original plan and budget. 

.      Executing and Closing Project: Develops and executes a work plan
obtaining authorized resources to ensure all activities are performed. Leads
team in delivering project scope. Gather lessons learned and obtain final
project approval from sponsor and stakeholders. 

.      Project Communication: Communicate project progress by producing
project reports to provide timely and accurate project status and decision
support information to project teams, business, and IT management. Makes
recommendations based on current project status to resolve issues and manage
risks. 

.      Resource and Team Management: Coordinate resources to ensure project
needs are addressed and effectively assign tasks and deliverables to team
members based upon their abilities. Motivates project team in order to
deliver project outcomes. 

.      Quality Management: Responsible for compliance with applicable
Corporate and functional policies and procedures. 

.      Decisions: Make decisions that impact project level activities. 

Qualifications: 

.      PPM Tool experience a must. 

.      Individual must be able to work full time; depending on start date,
may initially work in a remote setting, with transition to on-site in Lake
County. 

.      Primary Needs on page 1, reiterating that this position will require
experience in managing strategic projects and will be focused on strategy.
ISRM Technical experience will be a lower priority for any PM applying 

Preferred Qualifications: 

.      Experience with using Clarity PPM a plus. 

.      Familiarity with Organization Change Management experience/knowledge.


.      Note: no requirement for PMP or Pharma experience. 

 

Thanks & Regard's

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 719-7902 /C 224-635-0898
Email: ha...@dynamic-enterprise.net

 

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