Associate Clinical Data Manager
Statistics & Data Corporation (SDC)
- Hyderabad, Telangana
- Permanent
- Full-time
- Under supervision of Lead DM, perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
- Perform/Manage study conduct activities including listing reviews, query management, data transfers etc.
- Perform study closeout activities leading towards database lock.
- Serve as a backup resource to other Clinical Data Managers for issues pertaining to data management on multiple studies
- Assist Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities
- Performs independent central data review in support of various risk-based monitoring solutions; reviews reports, graphs, visualizations, quality tolerances, listings, key performance indicators to ensure cross site excellence and risk mitigation.
- Mentor all levels of Clinical Data Associates in their job responsibilities
- Maintain quality control of the data, project deliverables and closeouts
- Support and facilitate the review of medical coding for validity and completeness
- Participate in internal and external team meetings, as necessary
- Adhere to all aspects of the SDC’s quality system
- Comply with SDC’s data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
- Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
- Track and maintain audit-ready clinical study documentation within the electronic Trial Master Files for multiple projects
- Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process
- Excellent organizational and project management skills
- Experience in supporting study documents creation like the eCCGs, DMP etc.
- Experience in performing and leading UAT activities for a project with focus on quality.
- Familiarity with eTMF systems.
- Highly effective communication skills, both written and verbal
- Technical skills including EDC systems, clinical data management systems, Microsoft Office
- Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
- Bachelor’s degree, preferably in applied or life science, with at least 5 years of experience in data management of clinical trials or equivalent education and work experience
- We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
- We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
- We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
- With a proven track record, SDC has been successfully executing client clinical programs since 2005.