Innovaderm Research Inc.

Clinical Research

• Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements; • Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions; • Serves as a point of contact for CRAs and Lead CRAs for assigned projects; • Provides mentoring/oversight of CRAs and Lead CRAs; • Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance; • Contributes to the development of the Clinical Monitoring Plan; • Prepares and conducts project-specific training for the CRAs; • Develops the annotated site visit reports and monitoring tools such as source data verification worksheets; • Conducts quality control visits with CRAs; • Coordinates and leads CRA meetings; • Performs co-monitoring visits with CRAs; • May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)).

Clinical Trial Manager II

Clinical Operations

• Manage day-to-day operations of an assigned team in Clinical Operations
• Oversee performance, coaching, and training of Clinical Research Associates and support personnel
• Ensure proper monitoring and compliance with SOPs, GCP, and regulatory requirements
• Drive resources allocation and monitor adherence to project timelines and quality metrics
• Identify quality issues and establish corrective action plans
• Support training development and conduct assessments of clinical operations personnel

Clinical Operations Manager

Compliance

• Oversees Ethics Committee (EC), Regulatory Authority (RA), and other submissions to ensure compliance and timely delivery.
• Provides leadership for assigned projects and regulatory support to project teams.
• Prepares/reviews core packages and country packages for RA submission.
• Prepares, manages, and tracks IRB/IEC submissions as primary point of contact.
• Peer review of documents prepared by regulatory team colleagues.
• Reviews regulatory documents created by subcontractors for quality before submission.
• Acts as point of contact for regulatory bodies and local teams regarding submissions.
• Reviews and prepares study-specific regulatory documents/forms.
• Manages translations with vendors and oversees submission of SUSARs.
• Participates in meetings, audits, and project-related activities.
• Ensures TMF completeness through timely document submissions.
• Provides leadership and management to direct reports, including goal setting and mentoring.
• Participates in process improvement initiatives and other assignments as required.

Line Manager, Regulatory Affairs

• Coordinate regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions
• Provide regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise
• Provide guidance to the client on submissions strategies
• Prepare/review core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance
• Prepare, manage, and track IRB/IEC submissions (including renewals); acts as the primary point of contact for the central IRB/IEC
• Peer review of documents and packages prepared by colleagues within the regulatory team
• Review regulatory documents and submissions created outside of the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to RA and IEC
• Point of contact for regulatory body and IRB/IEC, Sponsors, investigative sites, subcontractors, and local teams for all aspects related to study regulatory submissions
• Develop/review Master Informed Consent Form (ICF), as applicable, and Country ICFs
• Review site-level Informed Consent form documents as needed
• Prepare or review study-specific regulatory documents/forms
• Manage/oversee translations and requests with vendor
• Submit and track SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, as per study scope
• Perform regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites
• Review country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements
• Participate in Kick-off meetings, client audits, and other project related meetings according to the company / client needs
• Submit documents to TMF in a timely manner during the trial and ensures the TMF is complete for assigned sections by performing completeness reconciliation
• Communicate activities performed out-of-scope to project team members and provides them with budgeting details related to said activity
• Maintain high level knowledge about regulations in the area of company interest
• Participate in function and/or corporate initiatives and special project assignments
• Support Regulatory Country Intelligence activities
• Communicate/liaise with regulatory agencies/competent authorities and/or other regulatory or functional experts on designated regulatory activities as required
• May provide presentations, training or help to develop tools and processes for the Regulatory Team or other cross-functional teams
• Provide line management to direct reports, including new-hire orientation, professional development, performance appraisals, and employee counseling/mentoring
• Management and coordination of resources and workloads of direct reports
• Supports staff by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level
• Promote a positive work environment and motivate the team to achieve organization goals
• Participate in the hiring process of new employees
• Provide leadership and implement productivity improvements to ensure optimal utilization of resources
• Participate in process improvement initiatives