Covance by Labcorp Job - 39548620 | CareerArc
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Company: Covance by Labcorp
Location: Bengaluru, KA, India
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Overview:

  • 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
Education/Qualifications:

Graduation or post graduation in life sciences or any other applicable qualifications

Experience:

8 to 14 years relevant clinical research experience with increasing levels of responsibility in clinical trial related roles


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