Clinical Data Manager

Company: Yoh ( Learn More )

General Information
US-NJ-Berkeley Heights
N/A
4 Year Degree
Full-Time
Not Specified
Not Specified
False
False
Job Description

Clinical Data Manager needed for a Contract opportunity with Yoh's client located in Berkeley Heights, NJ.

The Big Picture - Top Skills You Should Possess:

  • Clinical data management
  • Experience with EDC (RAVE)
  • CRO management experience
  • CRF and DMP design experience
  • Clinical trials (phase I-IV)
  • What You'll Be Doing:

  • Oversee the management of clinical trial databases from study start up to study closure.
  • Be able to review and understand protocol synopsis and attend if required any protocol review meetings and act as subject matter expert for proper data capture based on protocol requirements.
  • Lead Case Report Form Design according to the protocol with all Study Team members using established standards
  • Author and or review CRF completion guidelines
  • Develop or lead in the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, CRF flow, data queries, manual checks, coding, SAE reconciliation, third party vendor reconciliations, specification of data listings needed to facilitate data cleaning in accordance to a Data Review Plan, data lock and archiving, etc.
  • Develop and test edit specifications which may include the development of test scripts used for UAT as well as perform/coordinate UAT testing
  • When applicable ensure coding has been performed and reviewed by Medical Coder, Perform external data reconciliation, Provision of data management related metrics, provision of specific data listings as required by the medical group and review when necessary
  • Make data, including interim data, available to company personnel and to regulatory agencies when required
  • Trouble-shoot database issues with DBA until resolution is obtained
  • Perform database lock and freeze activities
  • Be experienced in the management and oversight of CROs and consultants
  • Be able to Review SOWs for data management activities and costs in contracts
  • Interact with CROs in the design and development of databases that are compatible with company needs, monitor progress of data management activities in CROs
  • Participate in regular team meetings and provide input when appropriate
  • Assist in database upgrades/migrations including performing User Acceptance Tests
  • Train Data Managers on standards and processes
  • Serve as the DM representative on clinical project teams that are developing NDAs
  • What You Need to Bring to the Table:

  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years of experience as a LEAD data manager in a pharmaceutical/CRO setting
  • Must be a Senior Level Person and familiar and experienced in all aspects of Data Management Responsibilities.
  • Must be familiar with all phases of clinical trials (Phase 1 - Phase 4).
  • Must have experience on Phase 1 studies as a Sr Level person assigned to more complex studies
  • Oncology experience
  • Proficient in writing function SOPs/Working Practices
  • Ability to interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
  • Experienced in understanding Sponsor responsibilities of oversight of a CRO.
  • Proficient knowledge of EDC preferably Medidata RAVE. Knowledge of JReview is a plus.
  • Basic knowledge of budget forecasting
  • Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Proficiency in regulatory guidelines, agencies, GCP
  • Advanced knowledge of clinical trial process and data management process
  • What's In It For You?

    We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

    If the most advanced technology to do your job is what you seek, this is the place to be. With the most progressive cultural of growth opportunities, this will be the company that leads you aspire

  • Medical, Dental & Vision Benefits
  • 401K Retirement Saving Plan
  • Life & Disability Insurance
  • Direct Deposit & weekly epayroll
  • Employee Discount Program's
  • Referral Bonus Program's
  • What are you waiting for? Apply Now!

    Recruiter: Kathleen McGurk

    Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

    Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

    J2W: CLINICAL; J2W: SCIENTIFIC;

    TAXTERM: CON_W2

    CB1

    Job Requirements