Records Management Specialist

Opko Biologics

Job description:

• Review of Clinical trial files for accuracy, completeness and ensure TMF inspection ready
• Preparation, handling, distribution, filing, and archiving of clinical trials documentation according to the scope of work and standard operating procedures
• Provide training and support to systems users (such as CTMS, eTMF)

Required qualifications:

• 1 year of experience in similar position in well-established CRO, pharmaceutical, medical device company or 1 year of experience as a Study coordinator – significant advantage
• Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, TMF RM – required
• Knowledge of regulatory requirements in the EU, APAC, East-Europe and south-America regions- significant advantage
• BSc/BA diploma or equivalent
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Ability to prioritize, self-control and diligence in completing big demanding projects
• Strong written and verbal communication skills including good command of English language
• Effective time management and organizational skills
• Permanent attention to details, accuracy in work
• Ability to establish and maintain effective working relationships with coworkers, managers and vendors

Job location