Job description
The Director of Monitoring and Site Management is responsible for overseeing the planning, execution, management and continuous improvement of clinical site monitoring activities. This position ensures the quality and compliance of clinical trials through effective site management, monitoring strategies, and the development of a high-performing, client centric monitoring team. The Director will work closely with cross-functional teams to ensure that clinical trials are conducted in accordance with all regulatory requirements and ethical principles.
Operational planning and oversight (25 to 35%)
- Guides the departmental planning and implementation process to transform strategic plans into measurable operational short – and long-term goals and plans.
- Ensures sufficient project level staffing and utilization.
- Supports implementation of efficient and effective processes, procedures and training plans to develop and maintain an efficient, adequately trained team that can perform at a high service and quality standard.
- Maintains a proactive approach to managing potential challenges related to team and site performance
- Works in conjunction with clinical operations leadership and project leadership team members to ensure that sponsor requirements are delivered.
- Develops and oversees strategy for site selection and activation, site monitoring and ICH-GCP compliant issue resolution.
- Ensures quality system work instructions and standard operating procedures for clinical operations support efficient study delivery and are aligned with work processes and internal SOP and work instruction guidelines.
- Oversees and guides team on continuous improvement of monitoring and site management processes.
Budget Planning/Financial Risk Management (10 to 15%)
- Oversees the budget for monitoring and site management activities, ensuring that resources are appropriately allocated, and costs are controlled.
- Works closely with Project Management team to identify potential study budget overruns, develop mitigations and provides impact into further budget planning
- Works in conjunction with the VP Clinical Study Delivery to plan and manage the MSM budget during the annual operational review process
- Oversees change order development for MSM services ensuring realization of project costs are achieved in line with work performed.
Unit leadership, team management and engagements (25 to 35%)
- Serves as a role model, motivator and mentor of the CRA/COL team and its managers, ensuring adequate staffing with appropriately qualified personnel.
- Leads and manages the Monitoring and Site management teams, ensuring a proactive, client and study delivery focused approach that is aligned with company objectives.
- Acts as senior representative of CRA/COL operations at client meetings.
- Supports Business development by assisting with development of cost proposals, bid development and defense as required.
- In collaboration with the Managers Monitoring and Site Management hires, trains, and mentors team members to develop strong monitoring and site management capabilities.
- Reviews and implements clear roles and responsibilities and performance metrics for CRA/COL team.
- Works with MSM Managers to conduct and oversee regular performance reviews. Provides feedback and professional development opportunities for team members.
Third Party Contract Management (10 to 15%)
- Identifies, procures and manages MSM (CRA) independent contractor services, including needs assessment, recruitment, contract negotiations, Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management, ensuring corporate, industry and regulatory service level, guidelines and regulations are maintained.
- Works closely with regulatory and regional directors/country managers as appropriate.
Strategy Leadership (10 to 15%)
- Contributing to strategic thinking around service augmentation and development initiatives.
- Supporting strategy planning around geographic expansion, collaboration and negotiations with CRO partners
- Anticipating alterations in the external or internal context and considering their potential influence on how services are delivered, and customers are served.
Qualifications
- 10+ years experience in related role, including supervisory and direct management experience.
- Minimum Honour’s Bachelor’s, preference for Master’s degree
- An equivalent combination of education and experience may be considered.
ADDITIONAL:
- At least 8 years in a leadership role managing clinical monitoring and site management teams.
- Experience with multi-site clinical trials and vendor management.
- Proven track record of managing large-scale clinical trials from start-up to completion.
- Strong leadership, organizational, and management skills.
- Excellent communication, interpersonal, and negotiation skills.
- In-depth knowledge of clinical trial protocols, GCP, regulatory guidelines, and industry best practices.
- Ability to handle multiple priorities and complex problems simultaneously.
- Strong proficiency in clinical trial management software and related tools (e.g., CTMS, EDC).
- Ability to mentor and develop team members in a high-performance environment.
Working Conditions
- Remote, some travel required (<25% of time) may be required to visit clinical sites or attend meetings and conferences.
$126,500 - $211,000 a year
+ bonus
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