Opportunity to join a global CRO focused on Oncology
As the Associate Director of Clinical Monitoring Operations, you will provide leadership, direction and support to the clinical monitoring team. The team includes CRAs, CMAs, project assistants/research assistants who are home based and/or office based. In addition, this role will oversee all US clinical monitoring activities and clinical monitoring team members and will have accountability for results to sponsors and internal clients.
Oversees assigned Clinical Research Associates (CRA/CMAs) and Project Assistants/Research Assistants and serves as primary contact for CRAs/CMAs regarding field issues.
Line Management duties for assigned CRAs/CMAs e.g. conduct of staff performance appraisals, mentoring of less experienced staff members and routine / periodic review of workload allocated to staff members.
Evaluates performance of CRAs/CMAs, including monitoring metrics, and provides feedback to CRAs/CMAs, Project Managers and Senior Management.
Trains CRAs/CMAs in general areas, including basic monitoring skills, SOPs and applicable regulations. Travels as required with CRAs to teach and to evaluate quality of work (e.g., accompanied field visits); conducts remote/virtual assessments and training wherever possible and appropriate.
Participate in internal, client/sponsor, scientific and other presentations as required
Manage and assist CRA's and Lead CRA’s activities with project team members to ensure efficient clinical monitoring and effective project completion.
Develop, implement and assess the training program for Clinical Research Associates in compliance with ICH-GCP applicable regulations and industry standards.
Ensures most efficient utilization of CRAs/CMAs.
Manages monitoring schedules of all CRAs/CMAs to avoid conflicts and to maintain efficient deployment of resources.
Identify monitoring resource gaps and escalate resourcing issues in real time.
Assists project management on monitoring questions/ issues and represents Clinical Management and the monitoring team at project/sponsor meetings.
Reviews monitoring plans, and monitoring templates for projects, provide input as needed.
Reviews and update SOPs relevant to monitoring.
Interview and hire CRA/CMA candidates; work with recruiter to identify qualified candidates.
Develop tools for monitoring performance and quality assessment.
Reviews and approves expense reports submitted by CRAs/CMAs to confirm adherence to SOPs.
Working with the Project Manager, acts as liaison between study site and the project team for monitoring- related issues at the study level.
Provide support to the Project Manager and Director, Clinical Operations for clinical monitoring issues as required.
Assist in the development and/or revision of clinical monitoring materials/documents/templates, e.g., SOPs, draft CRFs, protocol monitoring compliance forms, study prompters/calendars, study monitoring report templates.
Bachelor’s degree in a life science related field or equivalent with relevant formal academic / vocational qualification. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 8+ years).
Robust experience in Clinical Research, including experience as a Clinical Research Associate plus 3-5 years of experience as Clinical Manager (direct line management of individual CRAs and CRA teams)
Experience with early phase studies (including oncology studies) is preferred
Ability to travel up to 30%, possibly including international travel, as needed.
Skills and Competencies
Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
Solid leadership and management skills, including planning and execution.
Excellent interpersonal skills, including communication (verbal/written), presentation, persuasion, and influence.
Effective coaching and mentoring skills.
Ability to achieve goals and objectives by working independently as well as collaboratively in a team environment; ability to work effectively in a matrix organization.
Ability to anticipate and analyze complex problems relating to project monitoring and to develop and implement solutions.
Proficient in budgeting, forecasting and fiscal management related to the clinical monitoring resources.
University - Bachelor's Degree/3-4 Year Degree