Clinical Research Operations Manager

Skills:

Clinical Research Operations Manager We seek a highly motivated and experienced Clinical Research Operations Manager to join our team. The successful candidate will oversee the day-to-day operations of clinical research studies, ensure compliance with regulatory requirements, and manage study timelines and budgets.

Responsibilities:

Manage the planning, execution, and monitoring of clinical research studies Ensure compliance with regulatory requirements and ethical standards Collaborate with cross-functional teams to ensure successful study execution Manage study vendors and contractors Provide regular updates to senior management on study progress and issues Identify and mitigate study risks Ensure data quality and integrity Work closely with the Clinical Operations Director, Site Director, and Principal Investigators to coordinate all research activities on-site while ensuring protocol adherence and patient safety Serve and assist as the liaison between the Site and the Sponsor and FDA representatives Ability to multi-task and manage several projects in parallel, paying attention to detail Ensure that all clinical research duties are performed according to protocols, sponsor's guidelines, GCP & ICH guidelines, as well as local and FDA regulations Assist with Hiring and training all clinical department staff Team building and conflict resolution within the clinical team Assist the Clinical Operations Director in the process of seeking, vetting, managing, and training all vendors associated with the site Identify project issues such as resource, technical, or scheduling constraints, and assist in resolving issues internally and externally by performing risk assessments and developing summarized options and proposed solutions Ensure that projects are completed on time, within budget and scope, and conform to pre-established quality standards Primary contact to all the IRBs, CROs, Sponsors, and Study Vendors Assist during Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits Assist during Sponsor Audits and FDA Inspections Create GCP-compliant source documents and review all documents related to clinical trials Collect and distribute site metrics for internal departmental meetings and the site's Business Development department CTMS training and implementation Management of site calendar Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings

Requirements:

Bachelor's degree in a scientific or healthcare-related field Minimum of 5 years of experience in clinical research operations management Strong knowledge of FDA regulations and ICH guidelines Excellent project management skills Strong communication and interpersonal skills Ability to work independently and as part of a team Strong problem-solving and decision-making skills Proficiency in Microsoft Office and clinical trial management systems

Job Type:

Full-time Benefits:

Dental Insurance Health insurance Health savings account Life insurance Paid time off Vision insurance

Schedule:

8-hour shift Monday to Friday Weekend availability Ability to commute/relocate: Miami, FL 33172: Reliably commute or planning to relocate before starting work (Required)

Work Location:

In person