- The Associate Director, Clinical Operation is responsible for the overall coordination and management of clinical research project(s).
- The Associate Director Clinical Operations will support development activities from IND/CTX to NDA/marketing authorization by preparing, maintaining, and updating operational documents, reports/dossiers, or other documents for internal use and submission to regulatory authorities.
- The candidate will plan, establish, implement, monitor, and manage the clinical study projects according to clinical development plan in compliance with FDA/GCP/ICH. The candidate will oversee and take ownership of the quality of the clinical program conduct and compliance, clinical deliverables, and clinical data by managing internal or contract personnel or Contract Research Organization (CRO) teams.
- Development of core clinical documents, including: Clinical study protocol,Case report forms, Informed consent forms, Investigator manuals, Investigator files, and other necessary documentation for study initiation and conduct.
- Supports clinical investigators and/or CROs with preparation and submission of required documentation to IRB/ECs for approval.
- Manage clinical projects including the following activities:
- Project planning and clinical study implementation.
- Collaborating with cross functional groups with varied functional expertise.
- Establishing and monitoring clinical timelines.
- Implements and manages clinical timelines, milestones and strategy for individual studies.
- Manages vendor relationships including procurement, quality control, delivery according to specifications, and overall performance.
- Manages Contract Research Organizations (CROs) and other contractors, including CRAs and CTAs as applicable, to support clinical operations functions.
- Ensures clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, Institutional Review Boards (IRBs)/Ethics Committees (EC) requirements, and policies and procedures.
- Identifies, evaluates and identifies investigational sites to determine site qualification for participation in clinical trials. Manages CROs in the selection of investigational centers, as applicable.
- Is aware of IRB/EC reporting requirements, ensures maintenance of IRB/EC approval throughout the duration of the study and ensures compliance with national and international regulations.
- Prepares and provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary. Provides training of site personnel and project team as appropriate.
- Conducts periodic site monitoring visits/ co-monitoring visits as necessary.
Creates and implements processes to ensure that case report forms are completed and submitted by clinical investigators. Verifies data accuracy and performs or monitors data entry/verification.
- Ensures data quality by appropriate coordination across functions including site and source monitoring, data management, and clinical site oversight.
- Oversees operation to ensure all necessary documentation, including contract agreements are executed, signed and archived.
- Supports clinical study teams with the management of clinical supplies globally, including supply and re-supply planning, inventory management, and tracking.
- Provides status reports in compliance with federal reporting requirements to regulatory agencies, IRBs/ECs, Investigators and senior management.
- Tracks study progress, including regulatory document collection, competent authority approvals or requests, IRB/EC approval and enrollment, management of clinical supplies, safety, and deliverable timelines for internal reporting on the study progress and milestones.
- Participates in the analysis, summary and reporting of clinical data for regulatory or scientific purposes.
- Participates in the development and implementation of SOPs and Clinical Operations processes and systems including the development and/or update of policies and procedures to ensure continued compliance with changing domestic and international regulatory requirements and to align with corporate policies/procedures.
- B.S. or B.A. degree in science or related field.
- 7+ years clinical research experience in the pharmaceutical/biotechnology industry.
- Experience in managing clinical programs including staff and vendors pertaining to the management of clinical programs.
- Proficient and knowledgeable of the clinical research process, FDA and other regulatory authorities, as well as ICH and GCP guidelines.
- Demonstrated, effective project management skills including meeting project timelines.
- Willingness and capability to handle multiple projects and responsibilities within time constraints.
- Excellent attention to detail, good organizational skills, and ability to work with global teams.
- Travel within and outside the US.
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