Posted to MedZilla on 10/19/2018

Randstad Pharma

Clinical Operations 20422-MZ


Job Title: Associate Director of Strategic Monitoring

Position Description

The Associate Director (AD), Strategic Monitoring is responsible for the oversight of clinical monitoring activities, including but not limited to: managing activities of in-house Clinical monitors or monitors contracted through a Clinical Research Organization (CRO) or other monitoring resourcing entity. The AD, Strategic Monitoring is responsible for development, implementation, and oversight of monitoring approaches, such as strategic monitoring (RBM), remote data review, and key risk indicator review/action. This position will ensure monitoring processes are in conformance to all relevant laws, regulations, guidelines, policies and procedures and will take the lead on continuous improvement of internal monitoring processes. ?

Position Responsibilities

  • Creates and maintains relationships cross functionally with project management, site management, product development, Biostatitioners and Data management groups, and with external contract research organizations to ensure high quality of data in clinical studies through adequate management of risk signals and implementation of mitigation plans
  • Oversees the staff performing central monitoring of studies through interpretation of risk indicators and other trends, documents implications and provides status reports and identifies actions, follow up on completion of actions
  • Assists in the preparation of yearly budget and financial targets related to central monitoring aspect.
  • Lead the development and implementation and continuous improvement and optimization of the strategic monitoring activities, methodologies and generating detailed central monitoring group processes. This role will drive the central clinical trial monitoring activities across the various phases of the trial execution
  • This position is expected to provide guidance and training to the group of central monitors for the activities they are responsible for (the range of tasks will include activities such as providing input into the Integrated Quality Risk Management Plan (IQRM) plan, monitoring guidelines and targeted source data verification plan, ensuring historical site performance is gathered, performing trend analysis, maintaining oversight on key site risk indicators and ensure appropriate actions are taken by project management organization, monitor operational risk parameters at a trial level, checks of monitoring visit reports, lead lessons learned activities related to strategic monitoring
  • Participate in cross-functional risk assessment activities using the IQRM, including protocol- and site-level risk assessments
  • Participate in development and maintenance of clinical monitoring SOPs, tools, and document templates (e.g. monitoring plan and MVR templates)
  • Manage investigational sites to ensure adherence to scope of work, budget and study deliverables.
  • Contribute to monitoring contract negotiation and ongoing budget management
  • Participates on the cross functional clinical trial team (e.g., preclinical, manufacturing, data management, safety surveillance, regulatory, biostatistics, and quality assurance)
  • Manage day-to-day operations of the in-house monitoring staff including recruitment of staff, evaluation and communication of employee performance on an on-going basis, participation in compensation process, and direction and prioritization of staff workloads
  • Contributes to the preparation of relevant clinical program documents (study proposals, study protocols, monitoring plans and submissions)
  • Ensure the collection, accuracy and storage of study related documents
  • Oversee study monitoring activities for assigned studies and personally conducts site visits as necessary
  • Attend regular team meetings, assigning action items and due dates, as applicable
  • Ensure the review and tracking of monitoring reports for content, quality, adherence to GCP and timely submission
  • Proactively Identify risk, related solutions and implement plans, after management approval, in collaboration with the study team to ensure the study objectives, scope and timelines are being met
  • Develop Corrective and Preventative Action (CAPA) plans for issues of non-compliance

Position Requirements

  • A minimum of a BS degree or equivalent degree is required; Master's Degree or Equivalent is preferred
  • Minimum of 8 years of clinical research experience required
  • Clinical trials experience (i.e. clinical operations, data management, biostatistics, or other relevant clinical development experience) in the pharmaceutical industry or CRO with previous experience with strategic monitoring, risk based monitoring, targeted monitoring at a sponsor or CRO
  • Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information, independently make timely decisions
  • Strong GCP and regulatory knowledge including FDA and ICH regulations Ability to identify risk and trends required. Data analysis and technical skills in the area of clinical trials/clinical data is required. Strong ability to effectively communicate and understand issue escalation
  • Data analysis and technical skills in the area of clinical trials/clinical data
  • Ability to travel minimum of 30-50%


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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