Drives the clinical monitoring activities that support projects within each program. Provides leadership and direction to clinical monitoring team members throughout the project life cycle by establishing innovative processes and partnering with project, site and data management. Responsible for overall monitoring timelines and deliverables for trial portfolio.
Directly manages team of clinical monitoring personnel and oversees training program
Ensures staff are executing work in compliance to ICH/GCP guidelines and in accordance with internal SOPs
Drives strategic vision for monitoring operations, including monitoring systems, procedures and partners
Lead and actively participate in the implementation and execution of clinical research projects and new initiatives from project planning through closure.
Point of escalation for project issues, provides a key role in problem solving, works with leadership to develop solutions, and responsible for issue resolution.
May assist in the design and development of additional project related documents (Case Report Forms (CRFs), CRF guidelines/instructions, Data Management Plan, protocol, memos to sites, etc.).
Directs the development of the clinical monitoring plans, including risk-based monitoring criteria, and applicable monitoring documents.
Coordinates and communicates scheduling of monitoring/auditing visits. Assigns trips and helps to coordinate resources
Track and report to CIBMTR leadership on compliance, trends, and study metrics.
Works closely with clinical project manager, clinical site operations and clinical data management to ensure cohesive study execution
Other duties as assigned
REQUIRED QUALIFICATIONS: (Minimum qualifications needed for this position including education, experience, certification, knowledge and/or physical requirements)
Advanced written, oral, and presentation communication skills.
Advanced clinical trial monitoring experience, training, and conflict resolution skills.
Clinical research study processes, study design, GCPs and regulatory compliance guidelines for clinical trials.
Medical terminology and anatomy/physiology.
Communicate clearly and effectively to staff and management through oral and written formats.
Strategize to optimize resources effectively to meet timelines and deadlines.
Work proactively, take initiative and assess operational risk
Provide strong teaching and mentoring skills.
Travel up to 20% of time domestically.
Must exemplify our Be The Match Standards.
Education and/or Experience:
Bachelor’s degree in scientific or health related field
Minimum 6 years’ experience of current monitoring clinical research studies and/or protocol management according to ICH/GCP/FDA guidelines or verifying clinical data from medical records according to GCDMP.
Clinical monitoring/management experience including at least three clinical studies of increasing complexity.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
Master’s Degree in scientific or health-related field.
Clinical knowledge of blood and tissue cancers; immune diseases.
Internal Number: 2000004U
About Be The Match
Our Mission: We save lives through cellular therapy.
Our Vision: Democratize cell therapy. Equal outcomes for all.
For people with life-threatening blood cancers — like leukemia and lymphoma— or other diseases like sickle cell, a cure exists.
Be The Match connects patients with their donor match for a life-saving blood stem cell transplant. Be The Match provides patients and their families one-on-one support, education, and guidance before, during and after transplant.