Lead Clinical Data Manager

col-narrow-left   

Title:

Lead Clinical Data Manager

Job ID:

65174

Location:

Foster City, CA 

Classification:

Healthcare & Community, I.T. & T.

Salary:

$65.00

Salary Type:

per hour

Posted By:

Meera V
col-narrow-right   

Job Type:

Full time

Posted:

09/11/2017

Start Date:

-

Telephone:

9177162626
col-wide   

Job Description:

WE SPONSOR H1B CAP & CAP EXEMPT!!

Hello,
 
Im currently working on Lead Clinical Data Manager position. Please let me know if you are interested in applying for the same : 

JOB DESCRIPTION

Job Title: Lead Clinical Data Manager
Department: Clinical Data Management
Reporting to: Manager – Clinical Data Management
Location: West Coast USA (home based)


Role Purpose

The Lead Clinical Data Manager is responsible for the day-to-day operational activities of clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity is coordinated in conjunction with one or more vendors and, where appropriate, Clinical Operations staff. Mentoring and support of junior Clinical Data Management staff as expected.

Key Accountabilities:

• Act as Lead Data Manager for assigned studies. 
• Accountable for timely deliverables of all DM activities of their assigned projects
• Projection and management of Data Management study timelines
• Tracking of billable hours for the DM team against the budgeted hours
• Flag resourcing needs to the Team Lead as and when required
• Track and Monitor KPIs for their assigned studies.
• Complete project trend analysis of all issues flagged in the issue tracker for their assigned studies and discuss with the team to achieve quality data
• Ongoing internal oversight of study status and update the status tracker regularly and report to management periodically.
• Responsible for timely completion and quality of the study start up documents like eCRF/CRF design, aCRF, Data Management Plan, Data Validation Plan, eCRF completion guidelines etc. as applicable.
• Responsible for study set up of Clinical Data Management System (CDMS), and ensures completion of systems and tools to enable successful trial execution and reporting 
• Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy. This will include reviewing and resolving all discrepancies. 
• Ensure third party recon are delivered as per required quality and timelines for their assigned studies
• Track and Monitor the discrepancy status for their assigned studies to ensure quality and timely deliverables.
• Track and Monitor the SAE recon and Medical Coding status for their assigned studies.
• Perform Medical Coding activity for assigned studies as applicable.
• Perform close out activities for their assigned studies.
• Accountable for timely deliverables of all DM activities of their assigned projects

Communication:

• Maintains regular internal contact with relevant stakeholders such as Project Management, Medical Writing, Statisticians and others as necessary. 
• Attend meetings for project kick-off; investigator meetings, assuring investigators and site coordinators are well trained on the study; and attending project team meetings throughout the study. 
• Responsible as the primary contact with the sponsor/vendor in managing protocol execution


Training & Compliance

• Create CAPA and root cause analysis for assigned studies as applicable.
• Ensure audit readiness for their studies
• Participates in innovation and process improvement initiatives.
• Train the Internal staff on the study protocol, ensuring that staff understand the study set up and validation procedures 
• Mentor and support the junior data management staff as required.
• Provides input for definition of new or revised process development, problem solving, training, etc.as needed.
• Undergo training on study protocols and other DM related documents as applicable and ensure data cleaning is performed to the highest standard
• All assigned tasks are compliant with Standard Operating Procedures (SOPs), ICH-GCP and other applicable guidelines.
• Ensure compliance to trainings as per the training plan approved by the Line Manager

SUPERVISORY RESPONSIBILITIES:

• No immediate line management responsibility

EDUCATION/EXPERIENCE/SKILLS:

Education:

• Degree in related discipline and eight years of related experience; or,
• Equivalent combination of education and experience.

Experience:

In depth knowledge of CDMS systems such as RAVE with study set up and database lock experience

• Proven experience as a Lead Data Manager on large global projects

Knowledge/Skills/Abilities:

• Knowledgeable in Good Clinical Practice requirements 
• Extensive clinical research knowledge and cross-functional understanding of other operational departments
• Organizes and prioritizes numerous tasks and completes them under time constraints. 
• Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques. 
• Resolves a wide range of issues in creative ways.

JOB COMPLEXITY:

• Performs job duties with minimal / no guidance from the Manager 
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. 
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions. 
• Networks with senior internal and external personnel in area of expertise.

 
Company Info
The Veritas Healthcare Solutions LLC 469 7th Ave
New York, NY, United States

Web Site: http://www.theveritashealthcare.com/

Company Profile