Belcan
Job Title:
Clinical Trial ManagerLocation:
Northbrook, IL or Remote Pay:
$81-101/hour (DOE)Zip Code:
60062Start date:
ASAPA Clinical Trial Manager job is now available through Belcan.
This is a contract position with our key pharmaceutical client.
In this role, you will be accountable for the planning, set-up and execution of assigned drug trials which may include:
pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
Job
Responsibilities:
Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Leads or supports cross-functional trial teams, including vendors Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team Participate in or lead feasibility assessment and selection of countries and sites for trial conduct Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables 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 Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Provide oversight and direction to trial team members for trial deliverables Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems Ensure quality and completeness of TMF for assigned clinical trials Participates in inspection readiness activities including coordination of clinical trial team deliverables Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
Qualifications:
Required BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience Must have strong knowledge of ICH/GCP guidelines and regulatory requirements Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring Requires project management skills and trial leadership ability Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability Fluent in English Moderate ( 25%) travel requiredPreferred Advanced DegreeIf you are interested in the Clinical Trial Manager job in Northbrook, IL please apply via the apply now link provided.
Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors.
Belcan engineers better outcomes through adaptive and integrated services-from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity.
Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective.
Our unique capabilities have led to continuous growth and success for nearly 60 years.
We are a team-driven Equal Opportunity Employer committed to workforce diversity.
EOE/F/M/D/V.
About the Company:
Belcan.
Estimated Salary: $20 to $28 per hour based on qualifications.
Clinical Trial ManagerLocation:
Northbrook, IL or Remote Pay:
$81-101/hour (DOE)Zip Code:
60062Start date:
ASAPA Clinical Trial Manager job is now available through Belcan.
This is a contract position with our key pharmaceutical client.
In this role, you will be accountable for the planning, set-up and execution of assigned drug trials which may include:
pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
Job
Responsibilities:
Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Leads or supports cross-functional trial teams, including vendors Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team Participate in or lead feasibility assessment and selection of countries and sites for trial conduct Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables 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 Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Provide oversight and direction to trial team members for trial deliverables Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems Ensure quality and completeness of TMF for assigned clinical trials Participates in inspection readiness activities including coordination of clinical trial team deliverables Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
Qualifications:
Required BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience Must have strong knowledge of ICH/GCP guidelines and regulatory requirements Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring Requires project management skills and trial leadership ability Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability Fluent in English Moderate ( 25%) travel requiredPreferred Advanced DegreeIf you are interested in the Clinical Trial Manager job in Northbrook, IL please apply via the apply now link provided.
Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors.
Belcan engineers better outcomes through adaptive and integrated services-from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity.
Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective.
Our unique capabilities have led to continuous growth and success for nearly 60 years.
We are a team-driven Equal Opportunity Employer committed to workforce diversity.
EOE/F/M/D/V.
About the Company:
Belcan.
Estimated Salary: $20 to $28 per hour based on qualifications.
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