Posted in Health Care about 8 hours ago.
Type: Full Time
Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.
We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.
The Clinical Trial Manager (CTM) operates cross-functionally with global accountability for operational deliverables of clinical studies from Final Protocol Concept Sheet to Clinical Study Report (CSR) and applicable results disclosure. The CTM provides operational expertise and cross-functional management that enables the delivery of assigned trials within quality standards, agreed upon timelines and budget, and in alignment with applicable SOPs and regulatory requirements.
The CTM is assigned a subset of clinical trial management responsibilities under the guidance and supervision of a CTL/CTM who functions as CTT Lead. The CTM may lead the cross-functional Clinical Trial Team (CTT) for trials with lower complexity in partnership with the Lead Trial Physician. The CTM manages operational planning, global coordination, and implementation of assigned studies. The CTM establishes and maintains timelines & budget, conducts oversight of external partners, and oversees risk management and issue resolution, contingency planning, and decision-making. The CTM serves as the "Operational Voice" for assigned studies, both internally and externally.
Successful candidates have experience managing global clinical trial operations, CRO oversight, feasibility, start-up, execution, and study closure. They lead with humility and partner effectively to deliver with excellence.
ROLES AND RESPONSIBILITIES
The CTM is responsible for managing cross-functional execution of assigned global clinical trial(s) from preparation until closure. Responsibilities include:
If applicable, 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. Communicate in a transparent, clear way, and collaborate with CTT members & external partners to achieve clinical trial objectives.
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.
Manage CTT risk identification & mitigations, suggest and collaborate on solutions, manage contingency planning, and oversee implementation. Manage 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.
Contribute to the 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.
Oversee the country and site feasibility process, ensure cross-functional alignment on regional footprint.
Ensure timely availability of investigational product on site and ensure clinical site accountability records are in place and maintained.
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 manage resolution of issues/concerns.
Partner with argenx Site & Patient Engagement, CRO, and other vendors on recruitment & retention tactics that engage patients & sites and foster positive experiences. Ensure supportive relationships with clinical sites & trial personnel. Oversee and track patient recruitment.
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. Provides support during audits & inspections for assigned trials.
The CTM will participate in activities other than trial-specific which include, but are not limited to:
Provide feedback on the performance of cross-functional CTT members. Assist with onboarding new CTMs.
Embrace innovation. Recognize non-value-added activities and propose opportunities for improvement.
Share best practices & learnings.
Provide input to procedures, SOPs, WIs, and related documents.
Contribute to process initiatives within Trial Operations. Contribute to cross-functional improvement workstreams.
SKILLS AND COMPETENCIES
Leadership qualities and ability to establish good and effective internal and external working relationships and communication. Good interpersonal skills.
Good organizational skills to manage multiple varied tasks and prioritize workload.
Problem-solving skills with ability to identify and resolve issues, identify and mitigate risks. Able to maintain a holistic cross-functional view while diving into details as needed.
Good 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.
Minimum of 5 years of experience in Clinical Operations, including clinical trial management.
Biotech experience is a plus.
Rare disease, Auto-immune, and/or oncology clinical trial background is a plus.
At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.
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