Quality Recruiting. Established Experts.

Associate Director Clinical Monitoring

Reference Number: 3224
Location: MA or NJ

Our client is a global pharmaceutical company.  They have asked us to assist them in their search for an Associate Director, Clinical Monitoring.

Major tasks and responsibilities will include:

  • Ensures clinical monitoring activities are conducted in alignment with Good Clinical Practices (GCP) and relevant national and international guidelines/requirements.
  • Oversees and participates in clinical monitoring vendor selection process.
  • Contributes to clinical monitoring contract negotiation and ongoing budget management.
  • Ensures CRAs meet the company’s experience and performance expectations.
  • Oversees and participates in CRA training (GCP, therapeutic, and protocol-specific).
  • Reviews study protocols to recommend monitoring approach, including monitoring visit frequency, acceptable level of source document verification, and key risk indicators.
  • Develops, implements, and oversees risk-based monitoring (RBM) methodologies.
  • Facilitates cross-functional risk assessment activities using risk assessment categorization tool (RACT), including protocol- and site-level risk assessments.
  • Develops remote data review processes and assign action plans, as required.
  • Ensures study-specific monitoring plan is in place for each study, in alignment with the company’s SOPs.
  • Ensures monitoring visit reports (MVRs) and all relevant documents are generated, reviewed, and archived as outlined in the study-specific monitoring plan.
  • Collaborates with Clinical Trial Management (CTM) group to ensure clinical sites and investigators are conducting studies in compliance with ICH/GCP guidelines and study protocol; ensure CTMs are reviewing MVRs to identify potential compliance trends.
  • Performs or oversees co-monitoring visits to ensure CRA performance is in alignment with the company’s expectations and that monitoring is being conducted in alignment with ICH/GCP guidelines and study-specific monitoring plan.
  • Participates in development and maintenance of clinical monitoring SOPs, tools, and document templates (e.g. monitoring plan and MVR templates).
  • Mentors and trains in-house CRAs.
  • Manages day-to-day operations of the in-house clinical 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.
  • Participates in department and cross-functional process improvement initiatives.
  • Acts on constructive feedback from peers, supervisors, and colleagues to improve performance and provide feedback to direct reports and colleagues.

We seek candidates with the following qualifications:

  • More than five years of monitoring experience with lead CRA and global experience preferred.
  • Must have demonstrated proficiency in all aspects of clinical monitoring, including risk-based monitoring methodologies.
  • Must have experience in oversight of contract resources.
  • Must have familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.
  • Must have the ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Must have the ability to communicate in medical and scientific terms with vendors, consultants, and peers in English.
  • Must have experience interfacing and managing multiple vendors and contracts and the ability to manage time, multi-task and prioritize in order to complete deliverables on schedule.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3224. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.