New Remote & Local Opportunities - Contract
- Type Contract
- Salary competitive
- Location New Jersey, USA
- Sectors Clinical Research
Location: Greater NJ area
Duration: 12 months contract-to-hire.
About the Company
This company is actively seeking individuals with gene therapy experience.
The Data Manager will support the Director of Data Management in all data management activities.
Essential Duties and Responsibilities
- Participate in the review of Clinical Research documents (eg. Protocols, Case Report Forms, Reports and Statistical Analysis Plan).
- Work with Data Management CRO on the following
- Develop Case Report Form (CRF), electronic and/or paper
- Develop Interactive Web-based Randomization System (IWRS)
- Develop database (DB) clinical trial data specifications, user requirements, edit rules/checks, query logic and data validations
- Coordination of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report
- Reconciliation of electronic data transfers from vendor to Sponsor
- Coordinate/perform User Acceptance Testing (UAT) on EDC and IWRS
- Perform training on study trial for EDC, IWRS and create user guides
- Implement data cleaning plan and assist in data review, including the freezing and unfreezing of patient data within the EDC
- Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
- Assist in reconciling AE/SAE data in Safety DB and/or Data Management DB
- Coordinate coded data review/approvals using MedDRA and WHO-DD
- Participate in the preparation and presentation of data, when applicable
- Oversee all deliverables required for timely DB Lock
- Ensures data system compliance by following the established guidelines of national and international regulatory authorities
- Participate in conference calls and/or meetings with vendors and project team meetings
Education /Experience Required
- Bachelor's degree in scientific discipline or related field required
- Minimum of 5-7 years of Data Management experience to include essential duties above within a pharmaceutical, biotech or related environment required
- Working knowledge of Good Clinical Practices, Clinical Research, Clinical trial process and related regulatory requirements and terminology
- Working knowledge of Clinical database applications such as EDC, IWRS and CTMS
Other Skills and Abilities
- Applicable knowledge working with Medidata RAVE, Inform EDC, OC RDC, Oracle Clinical, SAS,
- Experience with working on Phase I-IV study trials within the pharmaceutical and /or biotechnology industry
Why this company?
This company is an established brand. They going through a very exciting growth period into many new therapeutic horizons. As the lead CDM you will be responsible for many new projects!
Sthree US is acting as an Employment Business in relation to this vacancy.