Clinical Operations Leader (CTM) - FSP

Benefits

Additional Information

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Clinical Trial Manager (CTM) accountable for the operational and scientific oversight, the set-up, execution and delivery of their assigned clinical trials at the regional/local level. CTMs contribute to delivery of pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites. The CTM provides leadership and direction to the Regional Operating Unit (R/OPU) trial team for their responsible R/OPU and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators. They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders and trial team members at a regional/local and global level. The CTM is responsible for managing the planning, implementation and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader("CTL") on all study-related issues. As leader of the R/OPU Trial team, the CTM communicates trial status to stakeholders, escalating issues as appropriate. The role is expected to be On-site (office) and Work from home. May required to commute to Client's office 2-3 times a week (Office location is Sydney) Key Accountabilities: Trial Preparation Accountable for the trial activities for responsible R/OPU, including but not limited to; Verify the trial is conducted in compliance with GCP-ICH, local/global regulations, application SOPs and according to the trial protocol by overseeing CRO and internal team activities. Creation, management and review of the R/OPU trial budget to verify appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes. Appropriate trial-specific training of R/OPU internal and external partners is performed in line with trial training plan. Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to verify trial team members are aligned and on track. Verifies and provides input into the country and site level feasibility and OPU commitment. Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions. Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus on patient value. Frontloading of activities where possible at the R/OPU level to facilitate efficiencies as well as to verify and leverage speed. Oversees outsourcing of vendor services in the R/OPU in accordance to operating models and governance. Verify timely responses to questions from Regulatory Authority/Ethic Committee and other external stakeholders Trial Conduct Maintains oversights during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring /mitigation. In collaboration with other functions, verifies budget oversight, including support of regular clinical quality monitoring, and safety reporting. Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughout trial conduct. Support CTL during investigator meetings Establish and maintain relationships with external experts, investigational sites, patient organizations and other stakeholders by coordinating and ensuring cross-functional collaboration amongst Clinical Development & Operations (CD&O) ad appropriate functions. Active participation in the CD&O community with a special focus on participating in the CTM network, to actively contribute to functional excellence. Trial Closeout and Reporting Verifies timely cleaning and delivery of clinical trial data. Responsible for timely, complete and compliant archiving of all relevant R/OPU documents in the TMF, including all required documents from vendors. Verifies timely submission of the Clinical Trial Report (CTR) to Regulatory au

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Parexel? Share your experience