Clinical Project/Program Manager at Kaztronix LLC in Durham, NC

Job description

• Clinical Project/Program Manager, Phase 2a Start-Up (PBGENE-HBV-01) — Temporary Engagement
• Vice President, Head of Clinical Operations and HBV Program Lead
• The Clinical Project/Program Manager (CPM) facilitates the detailed planning, coordination and operational follow-through required to move a global, APAC-first Phase 2a study in chronic hepatitis B from current planning through regulatory and ethics submission, site activation and first patient dosed, and supports the integrated start-up plan and critical path that holds that work together. Hong Kong and New Zealand lead, followed by additional APAC countries, and speed to submission and activation is the defining measure of the role.
• The CPM aides in the maintenance of the integrated start-up timeline, helps identify and drives the dependencies between Clinical Operations, Regulatory, Clinical Development and Medical, Translational, CMC and clinical supply, the CRO and other vendors, holds owners to agreed dates, and escalates risk before dates slip. The CPM works closely with Precision's HBV Program Lead and Head of Clinical Operations, and Precision’s existing Program Manager to facilitate day-to-day operations with the CRO and functional leads.
• This is a coordinating, integrating and driving role that operates within the program governance already established by the HBV
• Program Lead and Precision's existing Program Manager. The CPM does not own the HBV program or its governance, and does not substitute for functional leadership.
• Clinical Development and Medical own protocol, design and medical content; Regulatory owns regulatory strategy, technical submission content, regulatory interpretation and agency interactions; Translational owns translational strategy and content; CMC and Clinical Supply own IMP manufacture, release, labelling and supply execution; Clinical Operations owns operational feasibility, site strategy and sponsor oversight of site and CRO operations; Quality owns the quality system and applicable oversight.
• The CPM would facilitate integration of these workstreams into the start-up critical path and ensures their outputs arrive when the plan needs them. Program strategy, major cross-functional decisions and escalation to senior leadership remain with the Program Lead and Precision’s existing Program Manager.

Responsibilities

• Work with Program Management to build and maintain the integrated Phase 2a start-up plan and critical path — country sequencing and submission waves, package readiness, approvals, site activation and first patient dosed — and keep it as the single view of start-up against which all functions and the CRO report.
• Identify and drive the dependencies between functions, the CRO and vendors; identify agreed dates and facilitate accountability with Precision’s existing Program Manager; escalate risk with options and recommendations before missed milestones, through an established governance route.
• Maintain detailed start-up action, dependency and risk tracking, and feed it into the program RAID and decision logs maintained by Precision's existing Program Manager during existing meeting series.
• Support the CRO selection process now under way — bid defense, scope and budget evaluation, award recommendation, contracting and start-up transition — and manage CRO performance against the integrated timeline thereafter. This role picks up a selection already in flight rather than running a sourcing exercise from scratch.
• Assist Precision’s existing Program Manager track and challenge the start-up budget. Facilitate review of CRO, vendor and investigator site budgets and contracts with Finance, Legal and Program Management, and support review to signature against the dates the activation plan requires. Contract and MSA execution remains with Legal, Finance and Program Management.
• Track vendor deliverables and timelines against the start-up plan, and track budget and payment status where it affects submission or activation.
• Support tracking of start-up deliverables and dependencies across Clinical Operations, Regulatory, Clinical Development and Medical, and Translational. Functional leads retain substantive ownership of their strategy and content.
• Support Clinical Operations and Regulatory on country sequencing and site selection. Integrate feasibility outcomes and regulatory lead times into the start-up plan, and maintain the country strategy as that intelligence changes.
• Aide Study Start-Up execution with the CRO: submission to first-site active timelines by country, site selection and activation status, budget and contracting escalations with Finance and Legal, and weekly follow-up on CRO deliverables against the plan.
• Support Precision’s existing Program Manager with day-to-day operational contact with the CRO's project management and functional leadership during start-up — driving deliverables against the integrated timeline, challenging assumptions and estimates, resolving cross-workstream dependencies, and escalating performance issues early.
• Develop the integrated operational plan with Precision’s existing Program Manager against first patient in, and understand the enrollment assumptions — per-site-per-month rates, arm allocation, screen-failure allowance — that drive site and country requirements. Arm design, eligibility, dose selection and substantive enrollment strategy are cross-functional program decisions, not CPM decisions.
• Anticipate start-up issues and prepare contingency and recovery options with minimal oversight, including the alternatives available when a country, package or site slips.
• Monitor CRO and vendor performance against agreed KPIs and start-up milestones, address issues proactively, and work with Quality where a performance gap requires formal corrective action.
• Report start-up progress, milestone status, risks and budget variance to the Program Lead and the program team on the agreed weekly cadence, with the driver and a recommendation attached to anything that has moved.
• Communicate issues that affect the start-up plan to the Program lead and Program Manager and facilitate resolution of the issues with identified team members to closure.
• Support/Co-Facilitate start-up study team meetings with Program Management and drive the team to deliver the study to agreed timelines.
• Ensure start-up activities are conducted in line with ICH GCP, applicable regulations and Precision SOPs.
• Establish and maintain strong relationships with all internal/external partners and vendors, fostering a collaborative and productive environment.
• Drive completion of the CRO and vendor deliverables that are material to start-up execution, sponsor obligations and country and site readiness — for example the monitoring and start-up plans, TMF plan, EDC and IRT build and UAT, and lab and pharmacy manuals — and coordinate timely review and approval by the accountable functional SME rather than approving the content personally.
• Support monitoring of the timeline and dependency chain for the essential submission documents — final protocol, Investigator's Brochure update, IMPD and CMC pack, master ICF, and country ICF localisation and translation . The scientific and regulatory content of each remains with the accountable function.
• Maintain the integrated CTA/IND and ethics committee submission plan across APAC: package readiness, dependencies, submission and approval dates, CRO and local regulatory follow-up, and escalation when a package or approval is at risk. Regulatory strategy, technical submission content, regulatory interpretation and agency interactions remain with Regulatory Affairs.
• Facilitate integration of CMC and clinical supply dates into the start-up plan — IMP release, country labelling, import licences, depot set-up and first shipment — so that drug at site does not hold activation. CMC and Clinical Supply execute these activities.
• Track the country-specific gene therapy, GMO and biosafety steps that add elapsed time rather than paperwork — for example the Australian OGTR licence, the Japanese Cartagena Act determination, Singapore our financial client and Thailand GTAC — and reflect them in the critical path and country sequencing.
• Support Program Management for the green-light-to-screen gate in the integrated plan — regulatory and ethics approval, executed site contract, drug on site, systems live and training complete — and confirm all five before a site is declared open.

Requirements

• Bachelor's degree in a relevant field (Life Sciences, Business Administration, or equivalent). M.S./Ph.D. in a related life science discipline is preferred.
• Substantial clinical operations and clinical project management experience in global clinical trials, with demonstrated delivery of accelerated multi-country study start-up. APAC experience is highly valuable and strongly preferred; extensive complex multi-country start-up experience elsewhere will be considered, given the CRO and local regulatory expert support on this program.
• Hepatology experience, in particular chronic hepatitis B, is a desirable differentiator rather than a requirement.
• Gene editing experience is preferred but not required. Experience with CAR-T therapy, gene therapy, and/or oncology is also an asset. A transferable complex-modality background is acceptable in place of direct gene editing experience.
• Proven experience in phase 1, and phase 2a clinical trials.
• Direct experience moving countries and sites from feasibility and selection through regulatory and ethics submission to activation is required, and is the primary requirement for this role. Candidates must be able to say where start-up activities actually stall and what they did about it.
• Hands-on experience with CTA and ethics committee submissions in the APAC region is strongly preferred.
• Extensive experience in oversight and management of CROs, and other trial vendors. Sponsor-side oversight of a full-service CRO through start-up is required.
• Minimum 5 years of experience in clinical research, including management role as a team leader or project manager.
• PMP Certification preferred.
• Minimum 3 years of experience in clinical trial project management
• Strong negotiation, budget and contract management skills.
• Excellent communication, organizational, and problem-solving abilities.
• Strong knowledge of ICH GCP, regulatory requirements and industry standards related to vendor management in clinical research.
• Able to operate with minimal ramp-up. Timelines are compressed and the program cannot absorb a long onboarding period.
• Comfortable holding functional leads and a CRO to dates without owning their technical content, and escalating early rather than absorbing slippage.

Skills

Required

• Global clinical trials
• Accelerated multi-country study start-up
• Phase 1 and phase 2a clinical trials
• CRO and vendor oversight
• Minimal ramp-up

Preferred

• APAC experience
• Gene editing experience
• PMP Certification