Country Lead Monitor (CLM)

[Your Tasks and Responsibilities]

1. Directly manages and develops 8-12 staff combined of Country Lead Monitors. Assures hiring, training, development, compensation and advancement are in line with talent and job expectations. Through effective management and development of direct reports, the Team Leader ensures quality and compliance as well as ensuring country’s objectives are met.  Provides expertise and strong leadership and management to direct reports and maintains a motivated and competent staff.

2. Ensure projects/studies are resourced appropriately by allocating or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of direct reports. These activities are done in close alignment with Country Head and peers.

3. Accountable for all operational activities related to global and country procedures applied in the site management of applicable Phase I and all Phase II-IV clinical trials. This includes country feasibility, site selection, site initiation, patient enrollment and data cleaning processes direct reports are responsible for. The GSM Local Team Leader assures that each direct report delivers high quality study data required to support ethical standards and regulatory submissions in compliance with global operating standards.

4. Responsible for managing internal costs associated with direct reports and participates in the Country Head of Site Management’s preparation and tracking of the overall departmental operating budget. Responsible for tracking costs of direct reports appropriately and provides estimates and accruals to Country Head on a monthly basis.

5. Quality Oversight - Oversees Corrective Actions / Preventive Actions (CAPAs) of direct reports to ensure timely and sufficient resolution. Conducts Oversight Visits for each Site Manager as GSM expectations to ensure Site Managers are trained appropriately and to identify potential training or development needs. Participates in Audit Review Meetings and reviews all responses to audit findings prior to submission. Develops and implements training and development plan in a timely manner based on any deficiencies found or areas for improvement. 

6. Continuously and proactively identifies and proposes solutions for process improvement opportunities to Country Head GSM, and communicates best practices to entire monitoring staff.  Participates as member of Expert Working Groups and provides feedback on SOP updates.

7. Coordinates responses of audits with Global Quality Management. Proactively identifies actions to be taken at the country level to improve upon audit and inspection findings. Supports Country Head with follow-up of all Regulatory Inspections, Regulatory concerns related to investigator integrity, GCP and the veracity of all clinical data in NDA, CTD, PLA, SNDA and IND submissions.

8. Contributes to delivering Training programs developed by GCDO ICH-GCP Training as well as coordinating all training needs for permanent and CLMs.   Requires thorough understanding of global and local processes, Global Drug Development and associated Global Standard Operating procedures (SOPs). 

9. Contributes to development of country clinical investigator network to support the portfolio needs for clinical trials. Collaborates with Medical Science Liaison management to cultivate and enhance clinical investigator relationships to support business strategy

[Qualifications / Requirement]

The incumbent is a highly successful candidate with extensive professional and academic experience. Key competencies needed by the candidate include the following:

• Bachelor’s degree (or equivalent) with 8 years’ relevant healthcare experience including 4-6 years’ relevant clinical development or clinical operations experience
  
  
• In-depth knowledge of clinical development and drug development process, global clinical development processes, ICH-GCP, applicable legal, compliance and regulatory requirements
  
  
• Leadership, motivational, and collaborative skills are critical. Ability to lead staff in changing times as well as strong interpersonal skills in the management and development of people in a global environment
  
  
• Administrative, financial, and technical skills are required, as well as effective verbal and written English communication skills in relation to both internal and external colleagues
  
  
• Able to work effectively within a multi-cultural, global, matrix organization