Sr. Clinical Trial Manager

About the role

The Senior Local Operations Manager (LOM) is a key site-aligned partner responsible for streamlining communication across cross-functional stakeholders throughout the trial lifecycle. This role involves serving as the primary point of communication for sites, contributing to quality site selection, and ensuring high-quality data and timely delivery within budget.

Responsibilities

• 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.
• Contributes 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.
• Drives 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.
• Contributes 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.
• Works 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.
• Ensures 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.
• Organizes and ensures 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.

Requirements

• BA/BS degree in a health or science related field.
• 3 - 5+ years of trial end to end management experience.
• Start-up & Database Locks/Cleaning experience preferred.
• 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.

Qualifications

• Legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.

Skills

• Strong communication and interpersonal skills.
• Ability to manage multiple projects simultaneously.
• Strong organizational and problem-solving skills.
• Experience with clinical research and regulatory compliance.
• Knowledge of GCP guidelines and local regulations.

Benefits

• Variety of 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.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Pay

Compensation is competitive and commensurate with experience.

Schedule

Full-time position.