Job Title = Senior Clinical Data Manager
Duration = One year
Location= Berkeley Heights, NJ
Hours= 40 hr/week, 8am-4pm (with some flexibility in start/end times as long core hours of 9am thru 3pm are covered)
CORE JOB FUNCTIONS:
- Oversee the management of clinical trial databases from study start up to study closure at CRO (and or when required, support other DMs) by performing the following activities:
- a) 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.
- b) Lead Case Report Form Design according to the protocol with all Study Team members using established standards
- c) Author or review CRF completion guidelines
- d) 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.
- e) Develop and test edit specifications which may include the development of test scripts used for UAT as well as perform/coordinate UAT testing
- f) Ensure coding has been performed and reviewed by Medical Coder,
- g) Perform external data reconciliation, provide data management related metrics, provide specific data listings as required by the medical group and review when necessary
- h) Make data, including interim data, available to company personnel and to regulatory agencies when required
- i) Trouble-shoot database issues with DBA until resolution is obtained
- j) Perform database lock and freeze activities
- k) Prepare and present data collection requirements at Investigator Meeting
- l) Participate in CRO selection
- m) Review SOWs for data management activities and costs in contracts
- n) Participate in regular team meetings and provide input when appropriate
- o) Other Activities may include
- p) Interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
- q) Assist in database upgrades/migrations including performing User Acceptance Tests
- r) Serve as the DM representative on clinical project teams that are developing NDAs
- Requires BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 5 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.
- Experienced in understanding Sponsor responsibilities of oversight of a CRO.
- Immunology, Inflammatory and Clinical Pharmacology is highly desirable,
- Proficient knowledge of Medidata RAVE, Experience with RaveX is a plus
- Knowledge of of JReview is a plus.
- Basic knowledge of budget forecasting
- Proficiency in regulatory guidelines, agencies, GCP
- Advanced knowledge of clinical trial process and data management process
- Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
Sthree US is acting as an Employment Business in relation to this vacancy.