Clinical Study Manager

仕事内容

The clinical study manager is responsible for all operational aspects of the assigned clinical studies from initiation till closure of the studies. The successful candidate will have clinical study operational experience in phase I, II and III drug development phases and is an operational expert in the clinical study activities from start-up, execution until closure and its underlying activities. The CSM will be the “operational clinical study voice” for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical study project and is accountable to keep the study on track. The successful candidate will excel in establishing good and effective internal and external working relationships.

Key Accountabilities/Responsibilities

The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include:

• Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan
• Leading CRO contracts negotiations together with the argenx vendor manager
• Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc.
• Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays
• Ensuring that study Trial Master File is maintained and up to date
• Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations
• Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns
• Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained
• Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities
• Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation.
• Establishing and maintaining good relation with clinical site and study personnel
• Co-monitoring CROs personnel upon predefined plan
• Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager, Head of Clinical Operations or Senior Management, if needed
• Leading and guiding the internal clinical study team and chairing study team meetings
• Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
• Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan
• Ensuring that the assigned studies are executed according to the argenx quality standards
• Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken
• Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative
  

The CSM will also participate in activities other than study-related which include but are not limited to:

• Providing input to the clinical development strategy/plan
• Co-writing/maintaining SOPs within the Clinical Operations department
  

Desired Skills & Experience

• Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
• Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases)
• 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 and managing CROs and vendors
• Biotech experience is a plus
• Auto-immune and/or oncology clinical study background is a plus
  

Offer

• A competitive salary package with benefits;
• A work environment in a human-sized, dynamic, rapidly growing biotech company
  

Job Info

• Type: Full time
• Location: Gent