- Collaborates in the development of RBM proposal text & review of costing, contributes to proposal strategy and development
- May support RBM sponsor presentations / bid defenses.
- Ensures that tracking and status reporting are performed in a timely and accurate manner. Applies data to recommend any required changes
- Records Study Risk Assessment meeting and distributes Study Risk Profile to stakeholders
- Supports PMO in preparation of initial Risk Management Register and may prepare, distribute and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.
- Supports the Data Expert with Critical Data & Process Definition and EDC design implementation
- Conducts the Site Risk Assessment, works with study start up team members, reviews site outreach and Pre-Study Visit reports and prepares the Site Risk Assessment. Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels
- Supports the development of RBM requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.
- Drafts RBM and Central Monitoring plans and updates on an ongoing basis includes; documentation of prescriptive risk factor mitigation, risk assessment, remote monitoring, and site monitoring approaches and proposes centralized monitoring approach.
- Manages configuration of RBM tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of RBM tools
- Performs ongoing RBM dashboard review, prepares and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that RBM issues are followed to resolution in CTMS.
- Agrees potential changes to monitoring intervention level with project team in line with overall RBM and Monitoring plan, escalates to RBM lead.
- Reviews the Project Quality and Risk Reports for timeliness, accuracy and compliance.
- Manages and coordinates Central Monitoring activities to ensure consistency and effectiveness.
- Coaches / manages project team members to delivery RBM solutions.
- Applies P3 thinking to anticipate and recommend changes in study scope and risk profile.
- Manages internal stakeholders to effectively deliver the RBM and Central Monitoring Plan.
- Evaluates and collates process improvement suggestions and submits to leadership.
- Evaluates and submits ideas and justification for improved systems and tools to leadership.
- Any other duties assigned by supervisor
Graduation or post graduation in life sciences or any other applicable qualificationsExperience:
8 to 14 years relevant clinical research experience with increasing levels of responsibility in clinical trial related roles
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