The Global Clinical Trial Operations team is expanding and is looking for a Clinical Trial Lead.
The Clinical Trial Lead (CTL) is a cross-functional leader with global accountability for all operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results disclosure. The CTL provides operational expertise, strategic insights, and cross-functional leadership that enables the delivery of assigned trials within quality standards, agreed upon timelines and budget, and in alignment with applicable SOPs and regulatory requirements.
If established as the Clinical Trial Team (CTT) Lead, the CTL leads CTT in partnership with the Lead Trial Physician. Alternatively, the CTL may be assigned a subset of clinical trial management responsibilities under the guidance and supervision of a CTL who functions as CTT Lead. The CTL drives the operational planning, global coordination, and implementation of assigned studies. The CTL defines global operational strategy, establishes and maintains timelines & budget, conducts oversight of external partners, drives risk management and issue resolution, contingency planning, and decision-making. The CTL serves as the “Operational Voice” for assigned studies, both internally and externally.
Successful candidates have extensive experience driving global clinical trial operations in drug development phases I-IV, CRO oversight, feasibility, start-up, execution, and study closure. They have a strategic operational mindset with the ability to connect people, processes, and insights. They have the curiosity to embrace innovative and data-driven solutions. They lead with humility, partner effectively, and motivate & empower cross-functional teams to deliver with excellence.
The CTL will work with limited supervision or direction and have the ability to coach junior team members.
The CTL reports to the Clinical Operations Development Lead.
ROLES AND RESPONSIBILITIES
The CTL is responsible for leading cross-functional execution of assigned global clinical trials from preparation until closure. Responsibilities include:
- If assigned as CTT Lead, establish and lead the cross-functional CTT in partnership with the Lead Trial Physician. Work with functional leaders to assign CTT representatives from involved functional areas.
- Ensure clinical trials are executed according to protocol requirements, trial plans, OGSM, argenx procedures, ICH-GCP, and other applicable regulations. Set expectations, communicate in a transparent, clear way, and energize and motivate CTT members & external partners to achieve clinical trial objectives.
- Lead with minimal supervision and guidance from the CODL. If assigned as CTT Lead, coordinate the division of CTL/CTM tasks and maintain communication pathways to ensure a seamless delivery of CTL/CTM responsibilities.
- Accountable for delivery of global trials within agreed upon timelines and budget. Establish and/or validate/refine study timelines and budget leveraging internal & external benchmarks. Oversee cross-functional planning, track study progress, and proactively manage completion of trial deliverables and milestones.
- Responsible for leading, guiding, and overseeing CROs and other vendors to ensure contractual obligations are met according to plan and metrics.
- Oversee and drive CTT risk identification & mitigations, suggest and collaborate on solutions, lead contingency planning, and oversee implementation. Drive the implementation of corrective and preventative actions as needed. Maintain awareness of risks or issues that could have cross-indication, cross-franchise, or cross-asset impact and escalate to the (Franchise) CODL, Head of Trial Operations, and/or Senior Management as needed.
- Partner with Global Sourcing & Alliance Management (GloSAM) in evaluation, selection, and contracting of CROs and vendors. Ensure scope of work aligns with protocol requirements and established budget and timelines. Oversee contract management and ensure services are delivered per contract. Ensure accurate trial budget management, timely management of scope changes, and budget reconciliations.
- Ensure CTT members, including CRO and vendor teams, receive appropriate trial-specific training for their function. Oversee setup, coordination, and conduct of Investigator Meetings.
- Develop and/or contribute to trial-related materials such as the clinical protocol, study training materials, pharmacy manual, clinical monitoring plans, data management plan, eCRF and associated completion guidelines, patient information and informed consent, site instructions for specimen collection, patient recruitment and retention materials, etc.
- Act with the mindset of reducing patient & site burden throughout the trial.
- Ensure vendor systems and processes are configured according to protocol requirements & applicable regulations and implemented within established timelines. Contribute to the development and approval of project specifications, user acceptance testing, implementation, and change management. Evaluate new digital health technologies and oversee study-specific implementation as needed.
- Oversee the country and site feasibility process and ensure cross-functional alignment on regional footprint. If CTT Lead, provide endorsement as a member of the Country and Site Selection Commission for assigned trial.
- Ensure timely availability of investigational product on site and ensure clinical site accountability records are in place and maintained.
- Develop monitoring and site oversight strategy and oversee adherence to it. Perform site oversight visits according to plan. Review monitoring visit reports, protocol deviations, and data listings to ensure reliable quality data are delivered. Monitor data quality, completeness, and timeliness. Proactively identify and drive resolution of issues/concerns.
- Lead with the goal of positioning argenx as Sponsor of Choice for clinical trial participation. Partner with argenx Site & Patient Engagement, CRO, and other vendors on recruitment & retention strategies that engage patients & sites and foster positive experiences. Ensure supportive relationships with clinical sites & trial personnel. Oversee the effective collaboration, communication, and site engagement pathways across stakeholders (CRA, CTM, Trial Physician, Clinical Site Liaison, MSL, etc). Oversee and track patient recruitment; proactively identify ways to prevent recruitment delays.
- Ensure timely collection, documentation, and reporting of adverse events (AEs) and serious adverse events (SAEs) and collaborate in the submission of reports to regulatory authorities.
- Ensure the Trial Master File (TMF) is maintained and up to date.
- Ensure the CTT, CRO, and other vendors operate in a constant state of inspection readiness. Collaborate with Quality to ensure quality oversight of assigned trials utilizing available tools. Provide support during audits & inspections for assigned trials. If CTT Lead, function as the responsible contact person during audits & inspections together with Quality representatives.
- The CTL will participate in activities other than trial-specific which include, but are not limited to:
- If assigned to a trial where not acting as CTT Lead, can act as back-up to the Lead when needed.
- Provide feedback on the performance of cross-functional CTT members. May be involved in coaching & mentoring CTMs and CTT members and interview/selection process. Assist with onboarding new CTLs and CTMs.
- Embrace innovation. Recognize non-value-added activities and propose efficiencies to remove barriers and drive acceleration & cost savings.
- Proactively seek opportunities to share best practices & learnings across trial teams, including cross-indication and cross-asset.
- Provide input to procedures, SOPs, WIs, and related documents.
- Identify opportunities and drive process initiatives within Trial Operations. Contribute to cross-functional improvement workstreams.
SKILLS AND COMPETENCIES
Strong in leadership and establishing good and effective internal and external working relationships and communication. Strong interpersonal skills with ability to manage conflict.
Strong organizational skills to manage multiple varied tasks and prioritize workload.
Proactive problem-solver with demonstrated ability to identify and resolve issues, identify and mitigate risks. Able to maintain a holistic cross-functional view while diving into details as needed.
Excellent written and verbal communication skills, acting globally in a culturally diverse dynamic team.
Knowledge of ICH-GCP and other applicable regulations to successfully execute clinical trials.
Experience with tools and systems for managing clinical studies (MS Project, CTMS, TMF, IWRS, eCOA, eCRF databases, etc).
EDUCATION, EXPERIENCE AND QUALIFICATIONS
Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent by experience.
Global clinical trial management experience required. Minimum of 8 years of experience in Clinical Operations, including management and oversight of CROs and vendors.
Biotech experience is a plus.
Rare disease, Auto-immune, and/or oncology clinical trial background is a plus.
About Us
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, Japan, and Switzerland.
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