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Clinical Trial Physician
Deerfield, IL
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Medical Director/Clinical Trial Physician remotely. The Clinical Trial Physician will play a key role in a large global phase 3 lupus outcome study. In addition to the responsibilities described below, the CTP will be specifically responsible for reviewing participants medical conditions for study entry requirement. The tasks and activities of the Clinical Trial Physician will be carried out in close collaboration with the study Clinical Lead. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Providing medical leadership internally for the trial activities assigned, through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area
* Contributing to the core medical/scientific information required in all clinical documents of the respective trial (e.g. protocols, core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high-quality documents
* Supporting the Clinical lead by:
*Delivering medical oversight of the study (including safety, medical review of data during the trial, quality and performance of the trial)
* Answering to trial-related EC/IRB and HA questions
* Delivering medical training to the study teams members and staff and protocol-related training to study sites
* Plans and directs all aspects of an organization's medical policies, standards, and programs.
* Responsible for strategic clinical relationships with physicians and interns.
* Ensures all clinical programs are in compliance with all applicable regulations.
* Research and studies current medical publications and data on new treatments and practices to ensure high quality clinical service offerings.
* Advises non-medical management on clinical and patient related matters and policies.
* Manages a departmental function within a broader corporate function.
* Develops major goals to support broad functional objectives.
* Approves policies developed within various sub-functions and departments
EXPERIENCE
* At least 2 years' experience in clinical research in a Pharmaceutical and/or Biotech company or equivalent in Academia within lupus therapeutic area
* Typically requires 8-15 years of managerial experience.
* Experience in patient education is a plus
EDUCATION
* Requires an advanced degree in medicine:
* MD, Rheumatologist
To be a best-fit your strengths must include:
* Good knowledge of drug development and clinical trial process based on previous experience
* Good knowledge of regulatory requirements/ICH guidelines
* Good organizational and communication skills, able to work as part of a team and independently
* Results driven attitude and good sense of urgency
* Able to anticipate and proactively address issues and demands, solution oriented and hands-on
* Analytical thinking, data and detail oriented
* Shares knowledge and expertise openly
* Excellent written and spoken communication skills in English
509227
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
We are currently searching for a skilled professional to join a well-known client's team as a Medical Director/Clinical Trial Physician remotely. The Clinical Trial Physician will play a key role in a large global phase 3 lupus outcome study. In addition to the responsibilities described below, the CTP will be specifically responsible for reviewing participants medical conditions for study entry requirement. The tasks and activities of the Clinical Trial Physician will be carried out in close collaboration with the study Clinical Lead. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* Providing medical leadership internally for the trial activities assigned, through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area
* Contributing to the core medical/scientific information required in all clinical documents of the respective trial (e.g. protocols, core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high-quality documents
* Supporting the Clinical lead by:
*Delivering medical oversight of the study (including safety, medical review of data during the trial, quality and performance of the trial)
* Answering to trial-related EC/IRB and HA questions
* Delivering medical training to the study teams members and staff and protocol-related training to study sites
* Plans and directs all aspects of an organization's medical policies, standards, and programs.
* Responsible for strategic clinical relationships with physicians and interns.
* Ensures all clinical programs are in compliance with all applicable regulations.
* Research and studies current medical publications and data on new treatments and practices to ensure high quality clinical service offerings.
* Advises non-medical management on clinical and patient related matters and policies.
* Manages a departmental function within a broader corporate function.
* Develops major goals to support broad functional objectives.
* Approves policies developed within various sub-functions and departments
EXPERIENCE
* At least 2 years' experience in clinical research in a Pharmaceutical and/or Biotech company or equivalent in Academia within lupus therapeutic area
* Typically requires 8-15 years of managerial experience.
* Experience in patient education is a plus
EDUCATION
* Requires an advanced degree in medicine:
* MD, Rheumatologist
To be a best-fit your strengths must include:
* Good knowledge of drug development and clinical trial process based on previous experience
* Good knowledge of regulatory requirements/ICH guidelines
* Good organizational and communication skills, able to work as part of a team and independently
* Results driven attitude and good sense of urgency
* Able to anticipate and proactively address issues and demands, solution oriented and hands-on
* Analytical thinking, data and detail oriented
* Shares knowledge and expertise openly
* Excellent written and spoken communication skills in English
509227
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
2+ years
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