Title: Principal Clinical Data Manager
A global biopharmaceutical company that is focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders is currently looking for a principal 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. PCDMs will independently lead multiple, high volume and extremely complex studies within a development program. 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 report directly to the director of Clinical Data Management systems and work a visible role within this department. You will primarily be responsible for RAVE administration and implement this within the client's clinical program departments. You will perform EDC administration including core configuration including access reviewing and reporting. The main qualifications for this role will be outlined below, but proficiency in RAVE and years of experience as a CDM are the number one qualifiers.
- 7+ years CDM experience
- 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.
- Capable of working on multiple projects simultaneously, independently manage responsibilities according to deadlines, and define tracking tools to manage projects.
- 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 relevant experience
If you are interested in this PCDM position, please do not hesitate to apply!!!