Expert Clinical Manager
East Hanover, NJ, us, United States Contract
In collaboration with Trial Statistician, support of Reporting and Analysis Planning (RAP) modules in line with program standards.
Responsible to support development of and implementation of relevant data capture tools in collaboration with CSD, GTL and AQS as documented in data handling plan or equivalent document (e.g. CRFs protocol deviations, questionnaires, diaries, translation, edit checks)
Responsible for performing the ongoing review of clinical trial data as outlined in the data handling plan or equivalent , supports GTL to prepare database lock; and performing data reconciliation along the whole trila duration in collaboration with management.
Collaborate with Medical Lead/BSL to identify and safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT,GCT and GPT)
In collaboration with Medical Lead/BSL or CSD/CSAD, responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications and internal/external presentations.
Provide Support for biomarkers planning and or execution
May serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOP
May support CSD in limited program level activities
Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization. Work experience in clinical operations preferable.
Strong interpersonal skills
Ability to work under pressure
Excellent negotiation and conflict resolution skills
Collaborates across boundaries for shared success
Resolve issues with minimal supervision and understand when to escalate
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
Strong analytical / computational background
Demonstrates excellent Medical / scientific writing skills
Demonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze / interpret / report data effectively
Education:
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
PharmD, PhD or MD preferable.
Responsible to support development of and implementation of relevant data capture tools in collaboration with CSD, GTL and AQS as documented in data handling plan or equivalent document (e.g. CRFs protocol deviations, questionnaires, diaries, translation, edit checks)
Responsible for performing the ongoing review of clinical trial data as outlined in the data handling plan or equivalent , supports GTL to prepare database lock; and performing data reconciliation along the whole trila duration in collaboration with management.
Collaborate with Medical Lead/BSL to identify and safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT,GCT and GPT)
In collaboration with Medical Lead/BSL or CSD/CSAD, responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications and internal/external presentations.
Provide Support for biomarkers planning and or execution
May serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOP
May support CSD in limited program level activities
Basic knowledge in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization. Work experience in clinical operations preferable.
Strong interpersonal skills
Ability to work under pressure
Excellent negotiation and conflict resolution skills
Collaborates across boundaries for shared success
Resolve issues with minimal supervision and understand when to escalate
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process
Strong analytical / computational background
Demonstrates excellent Medical / scientific writing skills
Demonstrates knowledge and application of statistical analysis methodology and can identify trends and analyze / interpret / report data effectively
Education:
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
PharmD, PhD or MD preferable.
Neha Sharma
Lead Recruiter
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3437 | Fax: 973.998.2599
Website: www.artechinfo.com