- 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 qualifications
8 to 14 years relevant clinical research experience with increasing levels of responsibility in clinical trial related roles
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed