- Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business, as required.
- Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters. Meet/exceed client satisfaction expectations.
Initiation and Planning:
- Sets the project related clinical operations objectives and strategy in collaboration with the Core Team.
- Provide input into the development of feasibility materials and recruits potential investigators. Responsible for the final site list.
- Requests, manages and tracks clinical project resource needs.
- Provides clinical operations input into cross functional project plans.
- Develops the risk and contingency plans for key clinical operations activities in collaboration with the Core Team.
- Manages the successful design, implementation, tracking and revision of the monitoring plan and clinical operation training plans for assigned projects.
- Writes the prototype informed consent form.
- Provides clinical support to Global Site Services for regulatory submissions and IRB/ERC queries.
- Assists in the design of the CRF, EDC or equivalent.
- Owns the development of project-specific site and monitoring tools.
- Owns the development of training materials and training specific to the clinical operations team.
- Develops and presents the clinical operations training materials for Investigator Meetings.
- Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans.
- Responsible and accountable for the clinical operations budget for the project. Ensures that clinical operations activities are within budget and scope.
- Responsible for managing the clinical operations timelines as agreed with the client.
- Participate in internal project review meetings and provides clinical operations updates to the project management team.
- Responsible for the clinical management of approved sub-CROs. May also be requested to manage approved vendors for clinical activities or services.
- Ensures that all clinical operations staff allocated to assigned projects adhere to professional standards and SOPs.
- Ensures appropriate utilization of all assigned clinical operations team members.
- Responsible for timely and appropriate communication to the clinical operations team.
- Provide performance feedback of team members to respective supervisors.
- Ensure accurate and timely trip report completion and trip report review.
- Review and approve investigator grant payments
- Follow project issue escalation process and Covance’s Corrective Action Issue Resolution (CAIR) process for clinical operations issues.
- Responsible for clinical operations Corrective and Preventative Action plans.
- Performs co-monitoring visits when necessary.
- Ensure timely filing of relevant sections of the TMF.
Monitor and Control:
- Track client project metrics related to the clinical operations deliverables.
- Owns and implements the risk and contingency plans for key clinical operations activities.
- Coordinate activities and review progress of the clinical operations aspect of projects and initiate appropriate actions to achieve target objectives.
- Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects
- Track project progress against financial milestones using applicable financial systems. Review Time Analysis and provide monthly hours forecast.
- Consolidates resources to ensure financial viability during close-out.
- Ensures all site issues have been resolved.
- Ensures clinical operations sections of the TMF are complete.
- Coordinates archival of the clinical operations sections of the TMF.
- University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.
- Working knowledge of Covance SOPs.
- Experience as a Senior Clinical Research Associate, whether internal or external.
Minimum of five (5) years of relevant clinical research experience with an ability to demonstrate comprehensive understanding of:
- ICH/GCP guidelines;
- Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
- Site monitoring and study site management requirements; • Applicable regional regulatory requirements;
- Trip report review, risk planning, study plan development, resource planning and data management oversight.
- In lieu of the above requirements, candidates with > two (2) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
Additional requirements include:
- Demonstrated ability to work with minimal supervision.
- Demonstrated good planning and organization skills.
- Good computer skills with good working knowledge of a range of computer packages.
- Demonstrated effective and professional verbal and written communication skills.
- Ability to train, lead and develop junior staff.
- Ability to understand and work with financial information.
- Ability to resolve project-related problems and prioritizes workload for self and team.
- Ability to work collaboratively within a project team.
- Ability to work efficiently and effectively in a matrix environment.
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