Our quality of our personnel is reflected by our success. We are
committed to investing in the development and support of our
personnel. We believe that our people are our strength. We are
always looking for people with strong technical and academic
backgrounds, complemented by leadership skills, to join our
team.
| Position/Title: Clinical Applications Programmer |
| Location: Head Office | Status: Full Time |
| Reports to: Manager, CSD | Subordinates: None |
| Number of Available Positions: 1 | |
Job Description
The Clinical Applications Programmer is a member of the CSD team
who acts as a technical liaison between the system developer and
study project team members. Working closely with the Database /
Project Manager, he/she is responsible for programming custom /
complex online data validation and configurations for clinical
study EDC databases.
Key Responsibilities
Support Database / Project Manager in EDC implementation
kick-off and follow-up meetings with
clients
Assist Database / Project Manager with compiling and maintaining
study database requirements including those for online data
validation
Develop and configure study databases: design, data entry
screens, data validation programming, custom workflow and custom
status
reports
Assist in production of database design
documentation
Support database change management activities: propose
solutions, execute and document
changes
Assist SQA/Validation Specialist with creating and maintaining a
library of standard templates and practices, specifications,
documents, reports, tools, etc. for use by study
teams.
Other Duties
Assist CSD team with validation activities.
As
assigned
Qualifications
Required:
College diploma or Bachelor degree in Computer Science,
Information Technology, Health Informatics Technology, or related
field
In-depth understanding of database structures and database
programming
Basic knowledge of clinical trial process and clinical data
management
Knowledge of software development life
cycle
Strong oral and written communication
skills
Self-motivated, with the ability to learn quickly and
independently, and work within a
team
Demonstrated ability to problem solve
Desired:
Experience in Domino/Lotus Notes and working with EDC
systems
Experience working in a regulated (GCP) company
| Position/Title: Software QA / Validation Specialist |
| Location: Head Office | Status: Full Time |
| Reports to: Manager, CSD | Subordinates: None |
| Number of Available Positions: 1 | |
Job Description
SciAn Services is a CRO serving pharmaceutical clinical trial
sector specializing in EDC, data management and
biostatistics.
The Validation Specialist is a key member of the CSD team. He/she
is responsible for development and coordination of testing for the
company's computerized systems, including our proprietary EDC
system, and working with clinical study project teams to test and
validate EDC study databases.
Key Responsibilities
Work with CSD and project teams to identify test requirements
and design testing phases to meet system needs.
Develop and maintain validation documents such as validation
plans, test plans, test cases / scripts, traceability matrix and
reports as per defined validation approach, including change
management.
Setup test data, test system environments, and train and
coordinate project team members for execution of test scripts.
Participate and support in developing and implementing improved
SOPs and validation standards as required
Perform functional, usability, performance load-stress, &
user acceptance tests
Perform documentation reviews
Maintain validation documentation inventory and test
library
Other Duties
As
assigned
Qualifications
Required:
Knowledgeable of regulatory compliance requirements in the
pharmaceutical industry (GXPs), particularly those related to
validation, electronic records and electronic
signatures.
Familiar with various validation methodologies (SDLC), and their
implementation
College diploma or Bachelor degree preferably in Computer
Science, IT, Health Informatics or related technical
field,
1-3 years programming
experience
Minimum 3 years experience in software quality assurance role or
validation
Experience writing test
cases
Experience using issue tracking
systems
Excellent oral communication skills, and strong technical
writing skills including the ability to produce clear, concise
documentation
Self-motivated, with the ability to learn quickly and
independently, and work within a
team
Demonstrated ability to problem solve
Desired:
Validation experience or work experience in a regulated (FDA /
GxP)
company
Experience with Domino/Lotus Notes
environment
Experience in working with EDC systems
| Position/Title: Database / Project Manager – EDC Studies |
| Location: Head Office | Status: Full Time |
| Reports to: Manager, Biostatistics and CDM | Subordinates: None |
| Number of Available Positions: 1 | |
Key Responsibilities
Database Management
Liaises with Sponsor and end-users on database design and
management
Compiles and maintains study database
requirements
Oversees development and implementation of configuration plan
and data management
plan
Oversees design, implementation, testing and deployment of study
database (all platforms) and associated
documentation
Oversee development and maintenance of EDC user guide and other
database documents (e.g.
FAQ)
Conducts and manages end-user training (internal and external
end-users)
Manages and monitors database user
access
Oversees help desk and database change management
activities
Manages data transfers from 3rd parties and interim data
exports
Manages final database lock and audit activities (e.g. SAE
reconciliation, AE/CMED coding,
etc.)
Ensures the database documentation is consistent with study
database, and manages the release of the database and database
documentation as per SciAn
SOPs.
Oversees project closure activities (e.g. decommissioning of EDC
system, release of eCRFs to sites,
etc.)
Project Management
Establishes and manages the project per the project management
plan, study protocol and Sponsor
requirements
Ensures that all activities defined in the Project Management
Plan are executed and completed in a timely manner, within budget
and meet quality
expectations.
Leads and/or facilitates meetings with Sponsor and internal
project team, including EDC implementation kick-off and follow-up
meetings
Participates monthly internal project status
meetings
Other Duties
As
assigned
Qualifications
Required:
Bachelor degree in Computer Science, Information Technology,
Health Informatics, Health Sciences, or related
field
Experience managing CDM projects in an EDC
environment
In-depth understanding of database structures and database
programming
Solid knowledge of the clinical trial and data management
processes
Able to successfully work with a multi-disciplinary team and
communicate with internal and external
stakeholders
Strong oral and written communication
skills
Self-motivated, with the ability to learn quickly and
independently, and work within a
team
Demonstrated ability to problem solve
Desired:
Experience in Domino/Lotus
Notes
Knowledge of software development life
cycle
Experience working in a regulated (GCP)
company
SCDM
Certification
PMP certification
| Position/Title: IT Systems Administrator |
| Location: Head Office | Status: Full Time |
| Reports to: IT Manager | Subordinates: None |
| Number of Available Positions: 1 | |
Job Description
Reporting to the IT Manager, the Systems Administrator is
responsible for deploying, maintaining and troubleshooting the
systems and services that form the electronic client service
offerings and basic management infrastructure for SciAn. This
includes, but is not restricted to, customer data repositories,
inventory services, authentication services, monitoring services,
corporate web services, and CRM services.
Key Responsibilities
Maintenance of in-house LAN, servers and
workstations
Monitor system security and event
logs
Scheduled back-ups of
servers
Maintenance and control of Internet
Access
Maintenance and control of system access: user accounts, server
access, directory/file access
etc.
Manage and monitor network security: virus scans, firewalls,
etc.
Manage hardware and peripheral
systems
Upgrades of hardware and software
applications
Lotus Notes/Domino
programming
Periodic review and updating of corporate SOPs related to
IT
Other Duties
As
assigned
Qualifications
Required:
College diploma or degree in Computer Science, Information
Technology or related
field
At least 2 years experience in computer
programming
Knowledge of networks: architecture, design, security,
etc.
Knowledge of Lotus Notes/Domino
servers
Knowledge of system backup software