Senior Clinical Data Manager
This global biopharmaceutical is seeking to hire a senior level Clinical Data Manager for a year-long contract. This individual must have prior experience as a Data Manager lead.
The Senior Clinical Data Manager will be responsible for: 1) overseeing the management of clinical trial databases from study start up to study closure. 2) Review and understand protocol synopsis as well as attend protocol review meetings. 3) Lead Case Report Form Design & author or review CRF completion guidelines. 4) Make data, including interim data, available to company personnel and to regulatory agencies when required. 5) Assist in database upgrades/migrations including performing User Acceptance Tests. 6) 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.
Duration: 12-month contract
Location: Berkeley Heights, New Jersey (100% in-house)
Pay Range: $65-70 per hour (W2 or C2C)
- Education: Must have a minimum of a Bachelor's degree in a related discipline.
- Minimum of 5 years of prior Lead Data Management experience with a pharmaceutical company or CRO.
- Prior therapeutic experience within Immunology, Inflammatory and Clinical Pharmacology is highly desirable.
- Proficient knowledge of Medidata RAVE is required, Experience with RaveX & JReview is a plus.
- Must have working knowledge of CRO oversight/management.
- GCP and regulatory guidelines experience is mandatory.
Sthree US is acting as an Employment Business in relation to this vacancy.