- Provide clinical data management support to clinical development franchise(s) and related Clinical Operations team and/or study project, Safety, Clinical Management team and Biostatistics.
- Participate in the review of clinical research documents (e.g., Protocols, Case Report Forms, Reports and Statistical analysis).
- Partner with contract research organizations (CRO) and vendors that support our studies.
- Support overall quality and timeliness of clinical studies from study implementation to database closure.
- Collaborate with extended team on Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensure DMP is followed according to study design and requirements.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
- With Team input, develop Case Report Form (CRF), electronic and/or paper.
- Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations that are compatible with company needs
- Support EDC database (DB) specification process.
- Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Reconcile electronic data transfers from vendor to Sponsor.
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Support the integrity, confidentiality and security of all clinical data.
- Effectively communicate data management problems and delays
- Scientific background (B.S. degree or higher) with minimum 2 years clinical data management experience in the pharmaceutical/biotechnology industry.
- Applicable knowledge working with clinical databases such as Oracle, SAS, or other.
- Background in basic understanding of statistics.
- Ability to generate PowerPoint slides from data for internal and external presentations.
- Detail oriented while still maintaining work efficiency.
- Experience in MedDRA and WHO Drug coding preferred.
- Previous experience with EDC required.
- Experience supporting eCTD submissions through the creation of CDISC/SDTM standard datasets is highly desired.
- Ability to prioritize activities and multi-task across various projects at different study stages.
- Demonstrate a high level of personal leadership, be self-motivated, well-organized, and be able to think strategically.
- Exceptional interpersonal skills and problem-solving capabilities
- Flexible and cooperative with strong commitment to team efforts.
- Excellent oral and written communication and presentation skills.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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