| Job Description | Description
Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. Provides training to clinical operations staff and performs performance appraisals of direct reports.
Key Accountabilities/Core Job Responsibilities:
Responsible for the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
Responsible for the selection of investigators and study sites
Responsible for identifying and responding to site and study related issues and
recommending corrective actions and/or escalating to supervisor
Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
Ensure that CRF data queries are resolved
Coordinate and manage Investigational Product including overall accountability and reconciliation
Responsible for the preparation of study budgets and timelines
Manage project timelines and vendor performance to meet departmental and corporate goals
Manage study budget and payment process for all clinical trial vendors including investigative sites
Monitor and track clinical trial progress and provide status update reports
Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG)
Responsible for selection of CRO study staff and coordinating training including documentation
Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
Lead with minimal supervision in the planning of investigator meetings and making presentations, as required
Lead the review of clinical data at the CRF, data listing, and report table levels
Represent Clinical Operations at the Project Team level for individual studies, as appropriate
Partner with other research and development groups to achieve deliverables
Participate in Site Initiation Visits (SIVs) as required
Co-Monitoring of regional sites for adherence to protocol and GCP as required
Travel as required to carry out responsibilities
Identify and escalate site, vendor and study related issues to supervisor, as appropriate
Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
Perform other duties as assigned
Qualifications:
Must have demonstrated expertise in relevant clinical operations activities
Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
Good organization and planning skills
Strong interpersonal skills and communication skills (both written and oral)
Ability to problem solve and delegate appropriate tasks to subordinates
Knowledge of ICH/GCP guidelines and FDA regulations
Strong leadership skills, self-motivated, adaptable to a dynamic environment
Able to collaborate effectively with the study team, cross-functional team members, and external partners
Knowledge of ICH/GCP and FDA regulations
Proficiency in MS Word, Excel and PowerPoint
Able and willing to travel approximately 25-30%
Experience:
7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience)
Experience in oncology preferred
Experience in global trials preferred
Education Requirements:
BA/BS/MS in a scientific discipline |
| | Company | | Pharmacyclics | Job Code | | State or Province | | California | | |
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