Overview
The Clinical Project Manager (CPM) will report to the VP, Development Strategy & Clinical Operations and lead the end-to-end operational delivery of Alchemab sponsored clinical studies, with a focus on first in human (FIH) and early phase (Phase I/II) trials. Working closely with the Clinical Research Scientist, Translational/Biomarker Leads and broader cross functional teams, the CPM will plan, launch and execute studies on time, on budget and to the highest quality, ensuring inspection readiness and patient centric conduct throughout.
Responsibilities
Pre-Trial Activities
* Contribute to RFPs, vendor due diligence and selection process for Contract Research Organisations (CROs) for Trials. Develop and/or review Statements of Work (SOWs) and oversight plans.
* Partner with the Clinical/Regulatory Sub-Team (CRST) to translate clinical strategy into executable operational plans; provide input to protocol design on operational feasibility, country mix, patient pathway and site burden.
* Define country and site strategies, including feasibility criteria, start-up assumptions, recruitment planning and risk/mitigation approaches.
* Build the study timeline and critical path; align functional deliverables and establish governance cadence and decision logs.
Study start-up
* Drive study set-up activities (e.g., protocol finalisation inputs, site feasibility, essential document packages and regulatory submissions in partnership with function leads).
* Oversee development of core operational plans.
Trial delivery
* Perform all functions of the clinical operations lead as designated in the SOP on Clinical project management for any assigned trials.
* Serve as the operational lead and chair of the Clinical Trial Team (internal/external); integrate the work of all vendors and internal functions to meet study milestones.
* Manage the integration of all vendors and internal functions to ensure delivery against KPIs and quality tolerance limits; proactively identify risks, issues and dependencies and drive mitigations/CAPAs.
* Lead preparation and conduct of vendor governance meetings; manage change orders and scope control.
* Build, own and manage the clinical study budget; review and approve vendor invoices, accruals and re-forecasts.
* Prepare clear, concise updates for internal governance (e.g., CRST, Development Team, ELT) and external partners; maintain dashboards and status reports.
Keeping abreast of innovations
* Keeping up to speed on regulatory requirements and ethical parameters of conducting clinical trials.
* Understanding of changing market conditions in different geographies for the conduct of clinical trials.
Cross Functional team work
* Core member of the CRST and RFP/vendor selection groups for assigned programmes.
* Lead the Clinical Trial team (internal and potentially external) and act as operational delegate for the Clinical Research Scientist or VP, Development Strategy & Clinical Operations as appropriate.
* Provide mentoring and coaching to colleagues across functions where relevant, helping teams build capability, improve delivery practices and grow future leaders.
* Enable a positive, collaborative environment that encourages innovation, creativity and high performance through influence and example.
Champion a culture of diversity, equity and inclusion, ensuring all voices are heard and respected in cross-team work.
Essential
* Significant experience in Clinical Operations with proven track record as Clinical Project Manager delivering early phase (FIH/Phase I/II) studies.
* Demonstrated strength in vendor/CRO oversight, site performance management, budget ownership and governance.
* Experience managing both in-house and outsourced clinical studies.
* Exceptional communication, facilitation and relationship building skills, with the ability to collaborate and influence effectively with internal and external stakeholders.
* Deep working knowledge of end-to-end biotech clinical development, including ICH-GCP and UK/EU/US requirements, and how market dynamics shape study design, country mix and budgets.
* Highly organised, analytical and solution-oriented; able to operate with urgency and good judgment in a fast-paced biotech environment.
Desirable
* Advanced degree (Ph.D., M.D., or equivalent) in a relevant life science field.
NOTE: This job description is not intended to be all inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organisation.
Note to recruitment agencies: we are not looking for assistance at this stage so please contact the HR department only at hr@alchemab.com if you think you can help in the future.
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