Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
81d6a8c9d034df8d77908d6626cd18db

Principal Clinical Data Manager

DOCS Remote Home based, NC Full-Time
Apply Now

JOB TITLE


DOCS is currently seeking an experienced Data Management professional for a Principal Clinical Data Manager opportunity for a remote home based role.  


Responsibilities:

  • Senior/Principal CDM acts as a core team member of the Clinical Operations team.

    The role includes a variety of tasks related to oversight and management of CRO partners to ensure Data Management work is completed on time, on budget and in compliance for multiple clinical trials.

     

    Duties and Responsibilities:

    ·         Working with the CRO, provide Data Management expertise and support to project teams using Data Management best practices

    ·         Reviews study-specific Data Management Plans, procedures and guidance documents and provides feedback to CRO partners

    ·         Performs QC activities on CRO work

    ·         Provides functional support for study start-up

    ·         Performs User Acceptance Testing of the Clinical database

    ·         Reviews CRO metrics to identify trends, and drafts metrics slides for internal review boards.

    ·         Reviews study-specific invoice unit trackers for accuracy of billing units for each IC project. Communicates questions related to units to CRO partner.

    ·         Monitors planned versus actual consumptions and invoice units and escalates findings appropriately

    ·         Reviews study-specific invoices against agreed upon invoice units tracker. Communicates any discrepancies and questions to applicable Clinical Trial Manager

    ·         Follows-up on CRO corrective / preventive actions until resolution

    ·         May attend study-specific core team meetings

    ·         Identifies and appropriately escalate functional issues/concerns with CRO partners

    ·         Supports a continuous state of audit readiness

    ·         Collaborates with CRO on Data Management and trial operations improvements

Qualfications:


Minimum Education & Experience:

Education: Bachelor’s-level degree required.   

Professional Experience: minimum of 5 year experience in Clinical Data Management


Knowledge of Medidata Rave required

 

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

 

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

see description

Recommended skills

Clinical Trials
Clinical Data Management
Best Practices
Metrics
Product Quality Assurance
Operations
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.