SMA I

• Site Management Associate is responsible for end-to-end operational study delivery, with the focus on completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP) and supporting the study team in study coordination activities and administrative activities.
• Depending on experience and expertise, SMA may also contribute to development/review of study documents, vendor management, cooperation with Local Operating Companies (LOCs) and other internal functions, if required.
• SMA is considered a key role in ensuring inspection readiness state by taking an oversight over study eTMF completeness.
• SMA executes trial management activities, as delegated by Study Delivery Lead (SDL) for in-house and outsourced studies across all phases and therapy areas, in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice
• Working in close partnership with SDL and SDM, SDS plays a key role in successful study delivery, providing subject matter expertise across key processes and systems through the live cycle of the study.
• SMA role is implemented to have a broader impact on the business, by driving continuous improvement initiatives within their remit of expertise, sharing best practices across the business, with a focus on increasing efficiency operational delivery of studies.

• Setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed. Granting access to new system users.
• Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination)
• Support in managing the study team's communication: meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists etc
• Coordination of the study budget –managing expenses, tracking updates, checking consistency between systems and agreements and escalating issues of best practices

Depending on experience/expertise:

• May be involved in reparation and update of study documents and study plans, including, Monitoring Plans, Vendor Providing input to develop study specific processes and procedures, adhering to standardization and dissemination Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans etc

• May act as Local Operating Companies liaison / oversight – including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviations oversight, supplies’ availability, regulatory approvals and import license status approvals and import license status
• May be involved Vendor management & CRO oversight – agreeing on study-specific setup requirements, ensuring continued monitoring of agreed delegated activities
• May contribute to Risk management – contribution to maintenance of a comprehensive risk management plan and risk tracking
• May be involved in clinical supplies and recruitment materials management – having oversight on study level supplies availability, recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate

• University Scientific Degree or other related field
• At least two years on the similar position
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
• Able to think independently, analyse and solve problems systematically and creatively and able to take a risk-based approach

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others