Belcan
Details:
Job Title:
Clinical Trial LeadLocation:
Northbrook, IL or RemotePay:
$100-120/hour (DOE)Zip Code:
60062Start date:
ASAPA Clinical Trial Lead 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 and lead the day-to-day operations of assigned trials 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 trial teams, including vendor set-up, performance oversight and closeout activities Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team Lead feasibility assessment and selection of countries and sites for trial conduct Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders Participates in inspection readiness activities including coordination of clinical study team deliverables Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy Facilitate and manage regional KOL interactions, as applicable Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
Qualifications:
Required BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience Must have strong knowledge of ICH/GCP guidelines and regulatory requirements Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring Requires proven 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 Lead 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.
Job Title:
Clinical Trial LeadLocation:
Northbrook, IL or RemotePay:
$100-120/hour (DOE)Zip Code:
60062Start date:
ASAPA Clinical Trial Lead 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 and lead the day-to-day operations of assigned trials 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 trial teams, including vendor set-up, performance oversight and closeout activities Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team Lead feasibility assessment and selection of countries and sites for trial conduct Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders Participates in inspection readiness activities including coordination of clinical study team deliverables Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy Facilitate and manage regional KOL interactions, as applicable Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
Qualifications:
Required BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience Must have strong knowledge of ICH/GCP guidelines and regulatory requirements Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring Requires proven 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 Lead 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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