Job Description

Job Description

Plans, manages, and coordinates the execution of clinical study/studies according to regulatory requirements. Provides updates and ensures coordination between cross functional study team(s) to meet study objectives, on time and within budget. Provides guidance and mentors Program managers and handles additional sites.

Job Responsibility

• Provides strategic advice and guidance to the Operations function. Guides and trains Program Managers in the performance of operational duties ; provides guidance to Program Managers to improve effectiveness and achieve operational goals.
• Handles additional sites and acts as a resource for difficult or complex studies/ analysis ; gathers various metrics, analysis and reports findings to management within timeframes.
• Designs, develops and modifies systems and procedures to enhance departmental processing.
• Participates in cross functional study team(s) in protocol development, process development, data management amendments and administrative changes.
• Participates in creation and maintenance of business development activities and standard operating procedures and provides support during audits.
• Manages strategic partners, vendors, consultants for assigned studies.
• Performs the evaluation and selection of vendors, including contract and budget negotiations.
• Responsible for the day-to-day management of vendors, ensuring assignments, timeframes and budgets are met.
• Assists with site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of monitoring plans and Case Report forms and writing the Clinical Study Report.
• Identifies study risks, develop risk mitigation plans, including communication and collaboration with program management, and escalates risks and study issues, with proposed solutions, to management as necessary.
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience.
• 10+ years of relevant experience and 2+ years of leadership / management experience, required.

*Additional Salary Detail

The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).