Clinical Systems Specialist

The Clinical Systems Specialist plays a critical role in the implementation, management and optimization of clinical trial systems, ensuring their functionality and alignment with study needs. They collaborate with the System Administrator & vendor on system configuration to deliver features, fixes, and updates in alignment with the system’s roadmap, ensuring efficient operation and compliance throughout the clinical trial lifecycle. Additionally, they assist with system maintenance activities and act as the primary point of contact for training, end-user technical support, and communications, to ensure operational efficiency and compliance with internal & external requirements.

**System Development & Implementation (10-20%)**:

- Support the System Administrator in performing key system development lifecycle (SDLC) activities including requirements analysis, configuration and validation, system updates, and change control.
- Collaborate with IT and clinical teams to improve system efficiencies and automation, supporting continuous improvement of system management.

**System Maintenance, Security & Compliance (30-40%)**:

- Support user account management and access controls for compliance with regulatory standards and assist with user access reviews.
- Support audit activities (sponsor audits, vendor audits and regulatory audits) to demonstrate compliance
- Coordinates & executes data governance initiatives such as identifying opportunities for data cleaning, training end-users or other system support staff on data governance activities, and conducting oversight on these activities.
- Assist with system-related assessments including vendor assessments, risk assessments, and validation reviews, and audit trail reviews.
- Support necessary data inputs, lead and support data governance efforts, and configure or generate required reports or dashboards for end users

**User Support & Training (40-50%)**:

- Provide technical support to end-users and troubleshoot system-related issues.
- Provide training to end-users and collaborate with System Administrator on creation and management of training materials.
- Provide study-related services for end-users including study setup and publishing reports & dashboards, to support study reporting and compliance related study activities.
- Oversee user onboarding to system including assignment to system roles & studies.

**Qualifications**:

- 4 - 6 years of related experience
- (Honors) Bachelor’s degree

**Additional Knowledge / Skills**:

- Education in IT, software or a related field is preferred but not required
- Strong problem-solving and analytical skills
- Excellent communication and stakeholder management skills
- Ability to work independently and as part of a team.
- A minimum of 4 years of experience in clinical systems management, technical support, or a related role within the pharmaceutical, biotechnology, or contract research organization (CRO) industry is preferred.
- Experience working with clinical trial platforms such as clinical trial management systems (CTMS), electronic data capture (EDC) systems, electronic trial master file (eTMF) systems, or other platforms is essential.
- Previous experience in system configuration, validation, and troubleshooting in a regulated environment is highly desirable.
- Understanding of clinical trial processes, regulatory requirements, including GxP, 21 CFR Part 11, and other relevant guidelines.
- Knowledge of system validation procedures, including user acceptance testing (UAT), configuration management, and compliance documentation, is essential.
- Familiarity with clinical data integrity standards and audit processes is also required.
- Strong analytical and problem-solving skills with the ability to identify and resolve complex system issues independently.
- Excellent communication skills, both verbal and written, to effectively interact with technical and non-technical stakeholders.
- The ability to prioritize tasks, manage multiple projects, and meet deadlines in a fast-paced environment.
- Attention to detail and a commitment to ensuring the accuracy and integrity of clinical data.
- Ability to work independently with mínimal supervision while collaborating with cross-functional teams.
- Proactive approach to continuous learning and adapting to new technologies and industry trends