The Manager of Clinical Trials will execute clinical trials by supervising and overseeing field clinical research associates. An organized Clinical Trials Manager will implement and oversee projects and will ensure quality of clinical trials. The Clinical Trial Manager collaborates with the Project Manager to review clinical trial documents, make changes where necessary. The Clinical Trial Manager regularly visits Clinical Trial Investigators, issues them study drugs, Case Report Forms, and oversees Clinical Research Associate travel expenses and time sheets. You will gather Case Report Forms and ascertain their quality and collaborate with Clinical Trial Investigators to write final technical reports. Top candidates are proficient multitaskers, client-oriented, have successfully executed many successful clinical trials (in cancer preferred), experience managing a team, and have the ability to prioritize tasks.
GENERAL DUTIES AND ESSENTIAL JOB FUNCTIONS:
- Hires and supervises field Clinical Research Associates (CRAs)
- Collaborates with Project Manager to set targets for clinical monitoring and ensues recording of trial in compliance with project goals.
- Creating and implementing study-specific clinical monitoring tools and documents.
- Identifying, enlisting and recommending sites, and coordinating site management activities.
- Providing Clinical Research Associates with project-specific training and have regular meetings with them.
- Arranging and overseeing site visits in tandem with Clinical Research Associates.
- Gathering and examining trial documents.
- Assuring compliance to SOPs, FDA and GCP guidelines.
- Leads and/or participates in development and execution of training/mentoring programs, quality improvement processes and other projects, including development of SOPs
- Outstanding communication skills, both verbal and written.
- Ability to work independently and prioritize duties.
- Understanding of Electronic Data Capture (EDC).
- Experience working in a fast-paced environment.
- Ability to utilize resources available to effectively problem solve in clinical trials
- Ensure clinical trial is executed within compliance of regulations
- Identify areas of improvement to drive efficiency within Clinical Operations
- Bachelor’s degree in nursing or life sciences. Advanced degrees preferred.
- 5+ years work experience directly supervising field Clinical Research Associates to execute a clinal trial.
- Clinical research certification (e.g. SOCRA, ACRP) preferred
- Available to travel 50%.
- Oncology trial experience preferred.
Job Type: Full-time
- Clinical Research Management: 5 years (Preferred)
- Oncology Trial: 5 years (Preferred)
- Clinical Research (SOCRA, ACRP) (Preferred)