Provides ongoing technical application support for Ora’s clinical information systems. Assists on the builds, maintenance and administration of Ora’s Clinical Information Systems.
Assists the evaluation and implementation of various clinical information systems and data management platforms (EDC,CTMS, eTMF, eDiaries, payments systems, electronic regulatory filings, )
Helps ensures all clinical information systems are integrated/compatible within Ora and vendors.
Helps oversees the development of clinical information standards and support adherence to standards in EDC and other clinical systems
Provides ongoing administrative and technical support for all clinical information systems.
Provides systems training to end users.
Assists in developing and maintaining system, user and training documentation
Plays a key role in identifying potential issues and proposes solutions.
Ensures that clinical systems continue to meet expectations and make scientific and business sense. Develop and maintain external software vendor relationships; build vendor collaborations and partnerships.
Assists in ensuring clinical systems’ deliverables are aligned and meet clinical operations priority and deadlines.
Communicate timelines and assist in coordinating activities within and across functional groups.
Assists to ensure computer systems are validated and meet regulatory authority requirements.
Provide ongoing support for process improvement
Continue to develop clinical study management skills.
REQUIRED SKILLS AND ATTRIBUTES:
Knowledge of systems development life cycle, relational databases, database design, development and maintenance.
Familiar with clinical information systems such as EDC, CTMS, eTMF.
Understanding of clinical drug development process
Some project management experience.
Strong interpersonal skills.
Excellent written and verbal communication skills.
Excellent organization and time management skills.
Bachelor’s degree in computer science or information systems.
2+ years of hands on experience with clinical systems in a CRO