Job Details

ID #19887720
State Illinois
City Chicago
Job type Permanent
Salary USD BASED ON EXPERIENCE BASED ON EXPERIENCE
Source E-Solutions, Inc.
Showed 2021-09-19
Date 2021-09-18
Deadline 2021-11-16
Category Et cetera
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General Manager

Illinois, Chicago, 60290 Chicago USA

Vacancy expired!

Hi, Hope you are doing great We are seeking General Manager for the below position at Chicago, IL please go through with the below job description. Interested candidates who are local and willing to relocate can apply with your updated Resume and Rate Expectation. Please find the job description below. Job title- General ManagerLocation - Chicago, ILClient- Cognizant (End Client will reveal at the time of interview) Note - This is GM position - Onsite lead, its combination of someone who brings strong client / relationship management and good knowledge of LS. Job responsibilities: Position Details Job Title General Manager Job Location Alpharetta, GA Primary Skills: CDR, CDSM, DA, DWA, Medical Monitor, QL, Safety Management/Coding, SD, Site Management and Monitoring, SPM, Stats/Stats Programming, TA Leads, Vendors Secondary Skills: Bioanalysis, Document Management, DS SMEs (DTS, Labs, IRT, etc.), HEOR, LSO, Medical Writing, Outsourcing, PV, Strategic Study Start-Up, Tester, Vendor Management 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 & RegardsAbhilash OmerSr. Technical RecruiterE-Solutions Inc. Tel: 408-863-1838Email: abhilash.o@e-solutionsinc.com2N Market St, Suite # 400, San Jose, CA- 95113www.e-solutionsinc.comhttps://www.linkedin.com/in/abhilash-omer-06158096/ Disclaimer: E-Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability.

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