Clinical Trial Manager

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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