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Site Management Lead Level II

Remote, MA

Posted: 03/29/2023 Employment Type: Contract Job Category: Operations and Development Job Number: 3524

Job Description

The Site Management Lead (SML) is the primary point of contact for study specific questions from the Site Monitor (SM) team and will support the Lead Study Manager (LSM) in driving all site management activities. 

The SML, where assigned, will oversee SMs, ensuring consistency across a study for monitor training, monitor report review, monitoring oversight, and overall site monitor activities.  The SML will also support and oversee the development of and adherence to all site relations projects, processes and activities. The core duties and responsibilities include, but are not limited to:

  • Responsible for management of SMs at study level for clinical study site/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Clinical Monitoring Plan and associated documents
  • Support the LSM on monitoring oversight activities such as but not limited to monitor selection, site selection and other monitoring oversight activities as applicable
  • Assist LSM with creating and maintaining monitoring and/or monitoring oversight plans and study specific tools/trackers (e.g. SM FAQ and monitoring visit tracker).
  • Facilitate and/or support the LSM with study wide SM trainings and SM meetings.
  • Reviews trip reports, tracks and escalates risks to LSM.
  • Provide LSM with feedback on individual SM progress at sites.
  • Support the LSM in the review, tracking and reporting of monitoring and start-up metrics (e.g. CDA and contract status, site and SM performance metrics)
  • Co-monitoring as needed
  • May serve as SM at study sites depending on LSM delegation and/or study needs as applicable
  • Support LSM in audit/inspection activities as needed
  • Facilitates and/or supports remote and on-site monitoring activities, including training visits
  • Develops strong study team relationships within internal stakeholders
  • Promote positive site relationships and ensure continuity through all phases of the trial
  • Supports the LSM in reviews, and monitoring of required regulatory documentation for study start-up, study maintenance and study closeout
  • Supports LSM in risk and issue management, including development of corrective and preventative actions, relevant to site, SM and vendor performance.

Requirement /Qualifications:
  • BA/BS required, with preference for BA/BS with strong emphasis in health or medical science or equivalent
  • Minimum of 5 years required of direct site monitoring experience in a Biopharmaceutical, Pharmaceutical or CRO company, or equivalent
  • Prior experience in oversight or management of site monitors, management of global teams is required
  • Experience monitoring rare and ultra-rare disease, genetic disease preferred. Monitoring metabolic disease or pediatric studies, complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Neurology, Transplant, etc. is a plus.
  • Fluent in English and local languages where applicable (verbal and written)
  • Excellent communication skills and strong aptitude for conflict resolution
  • Strong knowledge of GCP/ICH requirements, and ability to work within country regulatory requirements and guidelines, as applicable
  • Knowledge and application of Good Documentation Practices
  • Ability to conduct assessment of site monitor and site performance and implement effective corrective actions
  • Demonstrated high level of monitoring skill with independent professional judgment
  • Proficient IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
  • Behavioral Competency Expectations:
    • Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
    • Works independently with high sense of accountability
    • Ability to create and modulate sense of urgency when needed and as appropriate
    • Ability to set priorities and handle multiple tasks simultaneously in a changing environment
    • Works effectively in a matrix environment
    • Ability to establish and maintain culturally sensitive working relationships
    • Demonstrates high quality and compliance mindset
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