Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives. Main Duties and Responsibilities:
We are looking for a Data Manager II to join our Biometrics department. This role will be based remotely in Hungary.
As the Data Manager II you will support the Senior Data Managers providing data review, reconciliation activities, coding and query creating and resolution tasks as required. You will also assist with the production of data management documentation such as the Data Management Plan and eCRF User Guide, and as required the eCRF Specifications and Edit Check Specifications.
You will provide support to the Senior Data Manager or Data Manager Team Lead in the eCRF Setup process by assisting with the user acceptance testing of eCRFs and edit checks within the EDC or SAS databases. Minimum Requirements: Essential: Previous Data Management experience within the pharmaceutical industry or a clinical research organisation Experience of working on studies using EDC databases Experience in study build activites, study conduct and database lock. Excellent organisation and time management skills Fluent in English Desirable:
- A degree or equivalent in any science subject.
- Experience in SAE reconciliation and Medical Coding
- Coaching and mentoring experience
- Experience in managing process improvement activities
- Expereince of working on oncology and rare disease clinical trials
Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.