Job Description
Functional Area: Clinical Data Management Systems Administrator
Position Summary: This is a multidisciplinary role: Clinical Data Manager, Clinical EDC/Database Builder, and Database Administrator.
Essential Areas of Responsibility: - Collaborate with other functions: Clinical Operations, Clinical Development, Biostatistics, IT, etc., to develop clinical database specifications, build EDC database or collaborate with EDC vendor on DB build, support integration activities with other systems such as CTMS, Safety & Pharmacovigilance (ARGUS), etc.
- Assist in user administration and operational support, including user and security management.
- Participate in selecting, implementing, and validating EDC tools and systems.
- Support and/or lead data reporting activities by gathering user requirements, developing report specifications, and implementing both standardized and ad-hoc reports
- Assist in creating necessary training materials and SOPs related to clinical database systems.
- Assist in the training of internal and external staff (when needed)
- In conjunction with the study team, develop Data Management Plans, Data Review Plans, and other applicable data management documents for completeness and accuracy.
- Create Data Transfer Plans for external data vendors for review and approval by study team members; perform external data reconciliations as applicable.
- Coordinate and support the internal data review process; perform data review periodically for quality issues and general data trends and communicate to team and/or CRO; oversee and track the ongoing delivery of clean patients by the CRO per established timelines.
- I oversee CRO data management counterparts for assigned clinical trials and ensure the data management objectives are met, following current SOPs, timelines, and budgets.
- Review protocols as requested and provide feedback while considering CRF design.
- Review Statistical Analysis Plans and statistical outputs, taking CRF/database into consideration.
- Develop and implement plans to oversee the data and database administration function and ensure a smooth transition to new technology.
- In conjunction with IT, perform routine and customary operational and monitoring activities to ensure the database environment is stable and capable of meeting ongoing business needs.
- Contribute to implementing and monitoring action checks within the EDC system to identify discrepancies or errors in data entry.
Generate clean and validated datasets for statistical analysis and interim/final reports.
- Generate or modify programs used for data cleaning (e.g., external checks, reconciliation between EDC and vendor), res, study metrics,c reconciliations, etc. This may be in SASdone or another software or an external data review and analysis application.
- Support the review of discrepancy output and validation listings, issue and track queries, and reconcile data from external databases and non-CRF data sources.
- Manage user access to Electronic Data Capture (EDC) and keep documentation current, as needed.
- Assist in setting up and maintaining Standard Operating Procedures (SOPs) and working practices for data management
Minimum Education, Experience, and Skill Requirements: Education:
- Bachelor’s degree in life sciences, computer science, or equivalent work experience required
Experience:
- 2+ years of experience in clinical trials at a pharmaceutical, medical device or CRO company
- At least 2 years of industry-related clinical data management experience.
- Experience with clinical data management systems such as EDC, including eCRF/database design/build oversight or hands-on experience is preferred.
- Excellent oral and written communication skills.
- Self-starter with the ability to work without supervision on short-term projects.
- Knowledge of and demonstrated experience with clinical data standards is preferred.
- Excellent organizational and priority management skills
- Knowledge of and experience with EDC for clinical data capture is preferred.
- Ability to interact in a cross-functional and multi-cultural team environment
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Knowledge and understanding of clinical development, FDA regulations, and Good Clinical Practices
- Technologically savvy with the ability to quickly pick up new information, standards and regulations, tools, and software as related to the role
- Proficiency in understanding software programming code
- Service-oriented approach, flexible, and proactive
- Must have superior attention to detail and excellent oral and written communication skills
- Must have the ability to work under pressure with multiple competing priorities
- Must have strong time management and organizational skills
- Knowledge of DM processes, including CRF development and data cleaning
- Good attention to detail; performing quality and accurate work
- Working knowledge of FDA regulations, ICH GCP guidelines, CDISC standards including CDASH and SDTM, and drug development process is preferred.
Job Tags
Full time, Temporary work, Work experience placement, Interim role, Flexible hours,