Clinical Trials Mgr

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><strong><u><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Commercial Responsibilities:</span></u></strong></p><ul><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Contribute to the operational plan and participate in the delivery of Bid Defense presentations for new business, as required. </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Develop and maintain relationships with assigned clients and serve as the client interface for all clinical operations matters. Meet/exceed client satisfaction expectations. </span></li></ul><p style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 9.0pt; font-family: 'Verdana',sans-serif;"> </span></p><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Initiation and Planning:</span></strong></p><ul><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Sets the project related clinical operations objectives and strategy in collaboration with the Core Team. </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Provide input into the development of feasibility materials and recruits potential investigators. Responsible for the final site list.  </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Requests, manages and tracks clinical project resource needs. </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Provides clinical operations input into cross functional project plans. </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Develops the risk and contingency plans for key clinical operations activities in collaboration with the Core Team. </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Manages the successful design, implementation, tracking and revision of the monitoring plan and clinical operation training plans for assigned projects. </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Writes the prototype informed consent form.  </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Provides clinical support to Global Site Services for regulatory submissions and IRB/ERC queries. </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Assists in the design of the CRF, EDC or equivalent.  </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Owns the development of project-specific site and monitoring tools.  </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Owns the development of training materials and training specific to the clinical operations team.  </span></li><li style="margin: 0in 0in .0001pt 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Develops and presents the clinical operations training materials for Investigator Meetings.  </span></li></ul><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Execution:</span></strong></p><ul><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Responsible and accountable for the clinical operations budget for the project. Ensures that clinical operations activities are within budget and scope. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Responsible for managing the clinical operations timelines as agreed with the client. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Participate in internal project review meetings and provides clinical operations updates to the project management team.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Responsible for the clinical management of approved sub-CROs. May also be requested to manage approved vendors for clinical activities or services. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ensures that all clinical operations staff allocated to assigned projects adhere to professional standards and SOPs.</span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ensures appropriate utilization of all assigned clinical operations team members. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Responsible for timely and appropriate communication to the clinical operations team.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Provide performance feedback of team members to respective supervisors. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ensure accurate and timely trip report completion and trip report review.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Review and approve investigator grant payments </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Follow project issue escalation process and Covance’s Corrective Action Issue Resolution (CAIR) process for clinical operations issues. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Responsible for clinical operations Corrective and Preventative Action plans.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Performs co-monitoring visits when necessary.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ensure timely filing of relevant sections of the TMF. </span></li></ul><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Monitor and Control:</span></strong></p><ul><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Track client project metrics related to the clinical operations deliverables. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Owns and implements the risk and contingency plans for key clinical operations activities.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Coordinate activities and review progress of the clinical operations aspect of projects and initiate appropriate actions to achieve target objectives. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Track project progress against financial milestones using applicable financial systems. Review Time Analysis and provide monthly hours forecast.</span></li></ul><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Close-Out:</span></strong></p><ul><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Consolidates resources to ensure financial viability during close-out. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ensures all site issues have been resolved. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Ensures clinical operations sections of the TMF are complete.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">Coordinates archival of the clinical operations sections of the TMF.  </span></li></ul><p style="margin-bottom: 3.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif;">The CTL may perform other tasks as assigned by the project team throughout the course of the project.</span></p><h2>Education/Qualifications:</h2><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Required</span></strong></p><ul><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">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.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">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. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Thorough understanding of the drug development process. </span></li></ul><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;"> </span></p><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Preferred:</span></strong></p><ul><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Working knowledge of Covance SOPs. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Experience as a Senior Clinical Research Associate, whether internal or external.</span></li></ul><h2>Experience:</h2><p style="margin-bottom: .0001pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Minimum of five (5) years of relevant clinical research experience with an ability to demonstrate comprehensive understanding of: </span></p><ul><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">ICH/GCP guidelines; </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs; </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Site monitoring and study site management requirements; • Applicable regional regulatory requirements; </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Trip report review, risk planning, study plan development, resource planning and data management oversight.  </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">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.  </span></li></ul><p style="margin-bottom: .0001pt;"><strong><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Additional requirements include:</span></strong></p><ul><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Demonstrated ability to work with minimal supervision. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Demonstrated good planning and organization skills. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Good computer skills with good working knowledge of a range of computer packages. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Demonstrated effective and professional verbal and written communication skills. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Ability to train, lead and develop junior staff. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Ability to understand and work with financial information. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Ability to resolve project-related problems and prioritizes workload for self and team. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Ability to work collaboratively within a project team. </span></li><li style="margin-left: 39.75pt;"><span style="font-size: 10.0pt; font-family: 'Arial',sans-serif; color: black;">Ability to work efficiently and effectively in a matrix environment.</span></li></ul>