Director, Field-Based Clinical Operations - Miramar, FL | Biospace
Get Our FREE Industry eNewsletter

Director, Field-Based Clinical Operations

Altor BioScience Corporation

Location:
Miramar, FL
Posted Date:
5/25/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management, Clinical Project Manager, Clinical Trial Manager, Immunology,

Job Description

Responsible for managing the field-based activities of several clinical studies including site initiations, periodic site visits (patient data monitoring) and close-out visits. Further, responsible for building and managing a field-based clinical operations team for such activities.

Specific Duties and Responsibilities:

•   Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and company Standard Operating Procedures.
•   Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits.
•   Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company SOPs, CFR regulations, ICH GCP guidance, and study protocol.
•   Facilitates study start-up activities. Draft/review monitoring plans.
•   Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective site and sponsor locations throughout trial conduct.
•   Notify and prepare team for regulatory agency audit and address any audit observations appropriately and in a timely manner.
•   Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
•   Other duties as assigned.

Requirements

•   BS/BA degree required in science/health-related field. A Master’s, RN or doctorate degree is preferred.
•   The candidate should have a minimum of 10 years of clinical research and/or clinical project management experience in domestic and international clinical trials.
•   Excellent working knowledge of ICH GCP guidelines, CFR, and HIPAA regulations.
•   Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward.
•   Excellent written and oral communication and presentation skills.
•   The ability to manage multiple priorities, while maintaining attention to detail is critical.