Senior Clinical Trial Manager

• Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
• Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
• Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
• Collaborates with central study team and local stakeholders as applicable for final selection of sites to participate in trial
• Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial
• Focuses on investigator engagement through timely follow up with sites
• Promptly communicates relevant status information and issues to appropriate stakeholders
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress
• When necessary initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams and Quality & Compliance team
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target
• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection
• This includes reviewing and approving site and local vendor invoices as required
• As required, manages the local study supply
• Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed (i.e. implementation of study amendment-and changes in study related processes)
• Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates
• This includes reviewing and managing site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements
• When issues are identified or trends across a project are noted from MVR review, will escalate deviation issues to TDM/TDL and J&J Sponsor in timely manner
• Accountable for ensuring quality data (accurate, valid and complete) is provided by the site and queries are resolved within expected timelines
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge enough for role and responsibilities
• With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits
• May conduct accompanied site visits with SM, if delegated by Sponsor
• Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines
• This includes forecasting and proactive management of country/local trial budget
• If applicable, may assist in negotiation of trial site contracts and budgets
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, as applicable
• May contribute as a trainer of systems/processes or provide input to functional area in process initiatives, if applicable
• Full utilization by timely and accurate time reporting
• Experience in management and startup of complex Early Phase trials projection with internal matrix clinical teams and sites, as applicable
• If applicable, region specific deliverables will be specified
• Autonomy with execution of local trial management services
• Depth of knowledge with local trial management services
• Process leadership

• BA/BS degree
• Degree in a health or science related field
• 3 - 5+ years of trial end to end management experience
• Solid Tumor Oncology experience required
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
• Strong IT skills in appropriate software and company systems
• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate
• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status

Start-up & Database Locks/Cleaning experience

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others