Job Posting |
The CTL is a member of the Core Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project. The CTL is responsible for coordinating and managing the clinical operations team, providing operational leadership and expertise to ensure successful execution of the clinical operations project deliverables (quality, timeline, budget and scope).
This role involves regular and proactive communication with the Sponsor, the Project Manager/Project Director and other functional groups, as appropriate. The CTL will serve as the main site monitoring and site management contact and support for the Project Manager and the client.
• 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.
• 1+ years additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Local project coordination and/or project management experience.
• Thorough knowledge of Covance SOPs regarding site monitoring.
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Covance Inc. is a drug development services company providing a range of early-stage and late-stage product development services on a...