Specialist (In-House Monitor)

What will you do:

The In-House Monitor is responsible for document review indexing andqualitycontrol aswell as filing within the Electronic Trial Master File (eTMF). This role involves performing risk analysis and centralized data review working cross-functionally with the Clinical Operations team tomaintainstandards of study quality and performance.

Technical Responsibilities:

• Performs essential document collection review maintenance and close-out activities ensuring that sponsor andinvestigator obligations arebeing metandare in compliance withapplicable local regulatory requirements and ICH/GCPguidelines.

• May serve as an Independent Essential Document Reviewer and/or perform second review of Essential Documents

• Performs study tracking via the CTMS or Sponsordesignatedsystem to ensure that the study files are currentaccurateand complete.

• Documentssite and Sponsor contact and study interactions ina timelyand professional resolution of investigational site/data with project team membersregardingstudy site issues.

• Performs study duties in adherence to the protocol Clinical Management Plan (CMP) study processes ICH-GCPandany other requirements stipulated on the study.

• Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow thetimelyprocessing ofInvestigator Payments

• In-house monitor assists lead Monitor and Clinical Study Managers in managing investigational sites tracking study timelines andensurecompliance withtrial protocol study plans and SOPs.

• Assists with Investigational Product accountability subject screening/enrollment Case Report form retrieval and query distribution to/from investigational sites.

• Proficient in the development and review of Informed Consent Form metric data toidentifyprocess improvements.

What You Need:

Preferred Qualifications:

• Minimum3-5yearsof work experience

• Clinical study and site level documents understandingTMF reference models (DIA / CDISC)

• Electronic trial master file. Centralized monitoring and Key risk indicators. Experience in medical device industry

Technical Skills:

• Document management and good documentation practice experience in internal auditing and site auditingisaddedadvantage

• Development of procedures processmetricsand dashboard

• Communication- Excellent written and spoken business communication skills in English. Systems - Microsoft Office eTMF (Medidata) or Veeva Vaultisrequired SmartsheetPowerBI

Education Requirements:

• Education Bachelorsdegree in Life Sciences Pharmacy Nursing or related field

• Holds valid GCP / ISO 14155 certification or a post graduate degree in clinical research andhas good understanding of medical and clinical research terminology (neurovascular preferred)