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Clinical Study Manager

Spectraforce Technologies Inc

This is a Full-time position in Atlanta, GA posted November 18, 2021.

Job Title: Clinical Study Manager (100% REMOTE)
Duration: 12 Months
Job Description:
BA/BS degree with at least five years multi-country clinical trial management experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience

• Pharma and Oncology experience desired

• Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.

• Requires proven project management skills and study leadership ability.

• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

• Must have strong knowledge of ICH/GCP guidelines.

• Fluent in English.

Moderate (25%) travel required.

Roles and Responsibilities:

• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements

• Manage and lead cross-functional study teams, including vendors

• Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues

• Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables

• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data

• Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team

• Lead feasibility assessment and selection of countries and sites for study conduct

• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans

• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.

• Provide oversight and direction to study team members for study deliverables; may provide direction to Associate Clinical Study Managers and Clinical Study Associates for assigned studies

Job Requirements:

Roles and Responsibilities:
 

• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements

• Manage and lead cross-functional study teams, including vendors

• Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues

• Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables

• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data

• Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team

• Lead feasibility assessment and selection of countries and sites for study conduct

• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans

• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.

• Provide oversight and direction to study team members for study deliverables; may provide direction to Associate Clinical Study Managers and Clinical Study Associates for assigned studies
 


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