Get job as soon as 2 days (HURRY UP) ENROLL NOW or Call   +1 (804)-454-3215
+

Clinical Data Manager


Job ID : 33160

Location : Princeton NJ

Company Name : Merit Technology Services

Job Type : Full-Time, contract, training

Industry : Healthcare

Salary : $25000 - $50000  per year

No. of Positions : 2-4


Required Skills : EDC, CDASH.

Benefits : None of These


Job Description :

Responsibilities:

· Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites) on a regular basis throughout the study

· Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)

· Provide support on clinical study database set-up, including eCRF design and database validation requirements

· Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements

· Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks

· Create training materials for EDC users and provide project-specific training as required

· Review and validate clinical data to ensure consistency, accuracy, integrity and completeness

· Create Data Cleaning Plan in consultation with applicable functional groups and oversee data

· releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)

· Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.

· Perform and/or coordinate various data reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data

· Perform Medical Dictionary for Regulatory Activities (MedDRA) and/or World Health

· Organization Drug Dictionary (WHO-DD) medical coding procedures

· Participate in conference calls and/or meetings with vendors and sponsors

· Keep track on project timelines and manage changes of scope, budgets and resourcing needs

· Keep oversight on relevant Data Management activities within a project, as specified in the Data Management Plan

· Manage the database implementation, lock and close-out processes and procedures

· Organize and distribute study data to facilitate statistical analysis and reporting

· Maintain documentation on an ongoing basis and ensure that all filing is up to date

· Plan and create necessary documentation to support internal and external audits; participates in such audits

· Provide leadership, guidance and support to other department members.

Skills:

· Proficiency with various computer applications such as Word, Excel, and PowerPoint required

· Strong written and verbal communication skills including good command of English language

· Representative, outgoing and client focused

· Ability to work in a fast-paced challenging environment of a growing company

· 2 years of Experience required

· Administrative excellence

 

Recommended jobs for you

  • Data Scientist

    Atechstar Claremont, CA

    Responsibilities : Design, develop and deploy AI solutions to elevate the quality and depth of Gartners data assets, ensuring high accuracy, reliability and completeness Lead the

    View Job
  • Android developer

    Atechstar Houston, TX

    Responsibilities : Roles and Responsibilities: Collaborate with cross-functional teams to design and develop scalable and robust Android applications. Write clean, mainta

    View Job
  • Java Developer

    Atechstar San Jose, CA

    Responsibilities : Roles & Responsibilities:  To succeed as a Backend Developer, you should be focused on building a better, more efficient program and creating a better

    View Job
  • Software developer

    Atechstar Chicago, IL

    Responsibilities : Roles & Responsibilities: Producing clean, efficient code based on specifications Testing and deploying programs and systems Fixing and impr

    View Job
  • Intern Data Analyst

    Talent Hire Consulting Remote

    Responsibilities : For quick response, please send your resume to [email protected]   A data analyst is a professional who is responsible for collecting, processing,

    View Job

Thanks For Your Feedback

We’re an equal opportunity provider.
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
OPTnation.com is not a Consulting Company/Training Company/H1B Sponsor.

Attach A Resume First