Job Description

Company Overview
Venture regulatory consulting company

Job Description
• Overall responsibility for the day to day management of the study/ project assigned in compliance with the applicable SOPs and regulatory requirements
• Central point of contact for external (e.g. Sponsor, Regulators, Vendors, etc.) and internal stakeholders (CRAs, Internal Management, etc.)
• Oversee trial progress to ensure compliance with and adherence to the project plans and to identify, evaluate and rectify any issues identified.
• Create Project Plans (e.g. Monitoring Plan, Communication Plan, TMF Plan, Recruitment Plan, etc.) for Sponsor Review
• Evaluate and nominate appropriate vendor/s for selection to participate in the study, as applicable
• Provide study specific training for the assigned project team members
• Ensure that recruitment of subjects for the study/ project is on target and identify action should there be any issues identified that will hurdle recruitment.
• Plan and conduct investigator meetings
• Oversee site/ Principal Investigator (PI) feasibility and selection process
• Ensure site visit compliance in accordance to the monitoring plan and scope of work
• Review site visit reports within the prescribed timelines
• Ensure completeness of Trial Master File (TMF) and Investigator Study File (ISF) and conduct quality check (QC) on a regular basis
• Facilitate internal/external audit and inspection by regulatory agencies as required
• Manage trial budgets and ensure that all are within the scope of work and escalate to Business Development team should any Change Order is necessary
• Negotiate site budget and oversee tracking of site payments
• Create Monthly Report on study/ project progress to track revenue, pass throughs, and other milestones
• Review and communicate with CRA to ensure timely CRF data entry and resolution of data issue
• Conduct regular meetings to CRAs/ Project Team
• Perform co-monitoring visits with CRA as necessary
• Perform Quality Visits to assigned CRAs to ensure data quality and integrity and compliance to ICH-GCP, applicable SOPs and regulatory requirements

• Responsible for overseeing the start-up process of the study
• Ensure regulatory document maintenance including document collection and submission to regulatory authorities and Independent Ethics committee (IEC)/Institutional Review Board (IRB) including drafting or creating additional documents as required
• Review Product labeling for compliance with applicable regulatory requirements
• Management of a process related the study drug including importation, returning to sponsor or destruction
• Point of Contact for Regulatory Authorities as necessary
• Ensure that sites are activated according to the agreed timelines/ milestones with the client