Safety System Support Engineer

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Create front end advanced conditions including query sets and generate custom reports from the ARISg/ARGUS database.
Implement automation to improve process efficiency and risk compliance.
Manage the Company Product Dictionary (CPD) and build automation to increase efficiency of on-going CPD changes and maintenance.
Manage high severity system issues with cross functional teams.
Develop and document standard and ad hoc reports from the safety systems.
Conduct routine and ad hoc data extraction (i. e. PSURs, DSURs, 6-monthly listings)
Ensure that search algorithms are clearly and consistently documented
Support and educate to end users and sponsors, if applicable
Audit for data integrity and consistency across systems
Maintain and document system configuration based on initial requirements and follow ups

Evaluate proposed project ideas / software changes through technical impact analysis and estimated business value to contribute to decision-making.
Provide overall guidance and strategize use of standard safety systems front-end reporting, including use of advanced conditions and Standard MedDRA Queries (SMQ)
Receive and respond user questions/issues and contribute to resolution of issues collaborating with technical support.
Collaborate with DDSS training liaison in development of safety system specific training modules
Manage safety system access requests (internal and external)
Prioritize and delegate daily workload for safety database team;
Maintain up-to-date knowledge of regulatory requirements for safety reporting as it relates to the safety database
Manage safety database upgrades and change control process
Serve as main point of contact for vendors and safety database related inquiries
Maintain and develop system related Standard Operating Procedures (SOPs) and procedural documentation
Oversee training of end users on any newly implemented functionality or technical changes
Provide guidance and leadership on additional projects as needed

EDUCATION AND EXPERIENCE REQUIRED:
BE or MCA or BSc Computer Science degree or equivalent.
5 years of technical software system administration and support experience in ARISg

COMPENSATION BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE:
Full Time, Permanent

COMMITMENTS:
Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed.
Willing to work in shifts as and when needed.

DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.