A biopharmaceutical company that is focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders is currently looking for a senior clinical data manager to oversee the the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. The individual will perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions.
In this position the candidate will work a visible role within this department. You will primarily be responsible for managing clinical data studies pertaining to oncology. You will perform EDC administration including core configuration as well as access reviewing and reporting. The main qualifications for this role will be outlined below, but proficiency RAVE, previous oncology experience and previous experience as a Lead/Senior CDM are the number one qualifiers.
- 4+ years CDM experience
- Previous lead/senior CDM experience is highly valued
- EDC experience
- Experience in vendor management of outsourced studies
- Medidata RAVE experience is required
- Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
- Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding preferred.
- Experience defining, entering, processing, reviewing and validating clinical data; and understanding and following clinical trial protocols and data collection documents.
- Experience in solving extremely complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements.
- Possess a thorough knowledge of Data Management SOPs and regulatory requirements, and be capable of providing guidance to and training peers.
- Bachelor's degree or above is preferred