HI ,
Hope you are doing great!!!
*Deputy Manager*
*Location Remote till COVID (after COVID- NJ, Irvine, California)*
*Rate :50/hr*
- It’s a role of Project Lead / Program Manager
- Need someone who can manage Clinical Data Management.
- Must to have skills: Clinical Data Management, Rave, ECRF, Project
Management
- Require 6-7 years of experience.
- Academics: Not necessary to have masters, Graduation in Life sciences
and healthcare will work.
Description and Responsibilities:
- Good understanding of clinical trials, fundamentals of clinical
research and GCP
- Sound knowledge of clinical regulatory guidance documents such as
ICH-E6, E3 and ICH-E9
- Good verbal and written communication skills along with good
interpersonal skills
- Overall Rave eDC (from set up till closeout) experience
- Knowledge of IVRS & ePro tools / concept
- Project management Experience
- Accountable to produce a data cleaning plan that, when executed as
designed, will produce a clinical-trial database that is fit for purpose
and adequate for statistical analysis
- Responsible for the timely application and implementation of the data
cleaning plan across the data collected for assigned trials
- Responsible for ensuring data management deliverables are executed
within scope, cost, time and quality objectives
- Responsible for the lock of assigned trial databases in a
regulatory-compliant manner and in accord with SOPs, process design and
time lines
- Ensures overall integrity and consistency of the study data by using
automated and manual methods to perform data review.
- Ensures trial data integrity and quality
- Ensures database lock activities and ensures all lock parameters have
been met before lock is executed
- Updates the data cleaning plan as necessary during trial conduct for
all assigned trials
- Executes all Data Science processes involved in the locking of the
trial database for assigned trials
- Liaises with the study team. Effectively communicates progress and
expectations around Data Science processes and the health of the study
- To perform, coordinate and ensure that discrepancy management
activities are implemented following study data handling plans.
- Ensures that global and study standards/conventions are followed
- Co-ordinate with assigned cross functional team to ensure data quality
throughout the study duration
- Utilize logic and reasoning to ensure edit checks quality as per
Protocol requirement
- Communicate with other study team members as required e.g. Clinical
team lead, stats, safety
- Support Study Design Group as necessary during study start up e.g.
attends identified meetings e.g. Clintech 1 and CAT
- When amendments are required, work with DA TL to ascertain level of
involvement from independently completing the amendment (eDC, IRT, load
specs, etc.) to passing off all activities to the Study Design Group
- Discuss major milestones (interims and locks) with DA TL and ascertain
if/when study will be transitioned back to client DA
- Discussion of timelines with TOL and maintain knowledge of general
project management.
- Ensure study documentation is up to date throughout the study and
submitted TMF/eTMF as appropriate. Maintain documentation to ensure that
documents reflect both the historical and current status of studies
--
*Thanks & Regards,*
*Thanks & Regards,*
*Vikritha Mustyala*
Tel: 703-831-8282 Ext. 253 <703-831-8282>9 .Fax: 7034392550
<703-867-7172>
Email: [email protected] Web: www.canopyone.com
<http://canopyone.com/>
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