Note: The job is a remote job and is open to candidates in USA. G3. GG Tech Global is seeking a Senior Clinical Data Manager. The role oversees clinical data management processes, study billing activities, project tracking, team supervision, and compliance with clinical research regulations and guidelines.
Responsibilities
- Identify inconsistencies and inefficiencies in data management process and recommend solutions
- Have a thorough understanding of the study billing guide, manage expectations with the support Clinical Data Manager(s) on the assigned tasks, available hours, and keep the billing guide current
- Forecast hours available against study activities and
- Assess if the study activities are in scope per the approved budget
- Work with the DM oversight role/manager in the change order process and ensure an approved change order is in place for any out-of-scope work
- Enter and verify the time spent on project and non-project work on InClin’s time Tracking tool regularly (daily time entries preferred, weekly at the minimum)
- Direct team members in daily activities including training and supervision study support staff
- Direct team members in daily activities including training and supervising study support staff
Skills
- 9+ years of data management experience and B.S/B.A in a science or technical discipline degree
- Proficient in MS excel
- Excellent oral and written communication skills
- Ability to work in a collaborative and multi-disciplinary environment
- Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines
- Availability to travel for clinical team meetings and / or Investigator Meetings if needed
- Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonization (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical of clinical development programs, especially as related to data handling and processing
- Previous CRP experience is strongly recommended
- Ability to program in SQL or SAS desirable, but not required
- Experience with various data collection and Electronic Data Capture( EDC) systems and related tools and processes. Medidata Rave EDC, Medrio eClinical and Clario EDC experience are preferred, but not required
Company Overview
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