Unlock Premium Benefits Today!
🚀 Elevate your career with priority access.
Stand out to top recruiters with Jobgether Priority Access:
  • ✅ Top Match: We help you identify job offers where you're a perfect fit.
  • ✅ Exclusive Referral Service: Connect directly with recruiters as a Jobgether Certified Premium User.
  • ✅ Personalized Feedback: Receive feedback and expert guidance on applications, and have your profile manually reviewed.
Go Premium

Director, Monitoring & Site Management

Offer summary

Qualifications:

10+ years of experience in clinical monitoring and site management roles, including supervisory experience., Minimum of an Honour's Bachelor's degree, with a preference for a Master's degree., Strong leadership, organizational, and management skills, with a proven track record in managing large-scale clinical trials., In-depth knowledge of clinical trial protocols, GCP, regulatory guidelines, and industry best practices..

Key responsibilities:

  • Oversee the planning, execution, and management of clinical site monitoring activities to ensure quality and compliance.
  • Guide departmental planning and implementation processes to achieve operational goals and maintain an efficient team.
  • Manage the budget for monitoring and site management activities, ensuring resource allocation and cost control.
  • Lead and mentor the monitoring and site management teams, fostering a client-focused approach aligned with company objectives.

Alimentiv logo
Alimentiv SME https://alimentiv.com/
201 - 500 Employees
See all jobs

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.
    • PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. 

    Required profile

    Experience

    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Hard Skills

    Web AdministrationRegulatory ComplianceClinical Trial Management SystemsBudget ManagementgRPCProject ManagementVendor ManagementClinical Trial PlanningClinical Monitoring

    Other Skills

    • Leadership
    • Communication
    • Negotiation
    • Organizational Skills
    • Social Skills
    • Problem Solving
    Are you interested?

    Related jobs

    See more jobs