Job Title: Clinical
Responsible to: Vice President, Clinical Operations
In this role, individuals can make an important contribution
to the company’s clinical development programmes and will be primarily
responsible for coordinating and managing all aspects of clinical study activities
to maintain regulatory compliance and meet company timelines and goals for the
clinical development program.
â€¢ Manage all
operational aspects for implementation of clinical trial activities from study
start-up through database lock, ensuring GCPs and relevant SOPs are met.
study-related vendors; identifying potential risks and resolving issues;
establishing vendor oversight plans and reviewing quality metrics.
â€¢ Write and
finalize protocols, amendments and other study documents such as study plans
eCRF forms and completion guidelines, site instructions for blood collection
and study drug order forms in consultation with appropriate team members.
monitoring reports, protocol deviations and data listings for sponsored studies
to ensure reliable quality data are delivered; coordinating with CROs on site
selection, IRB submissions, site initiation and close-out planning.
timely and effective communications within the clinical team and supporting
functional groups; tracking patient recruitment and progress to study
timelines; supporting safety reporting and IRB submissions; maintaining and
reporting metrics for clinical site performance.
and/or oversee site initiation, monitoring and/or close out visits for clinical
trials as needed.
the negotiation of site budgets within guidelines, and provide oversight for
the site payments per contracts.
site study drug orders and ensuring site accountability records are
oversight to staff maintaining clinical trial master files to ensure their
compliance with required regulatory and GCP quality standards and consistency
with Cell Medica SOPs or CRO SOPs as appropriate.
with CROs and provide support to sites to prepare for clinical audits and to
respond to audit findings conducted by internal QA and external regulatory
present at and participate in investigator meetings, project team meetings
other study trainings and meetings as required.
vendor selection processes as required.
â€¢ Act as
mentor and co-monitor with less senior CRAs and CTAs to ensure high quality as
Education and Experience
to degree level in a health or biologic based field (BS/BA/BScN or higher) is
required; post graduate degree is preferred
â€¢ At least 5
years (or equivalent) clinical study management experience in biopharmaceutical
industry, including a minimum of 2 years in oncology, immunology and/or cell
therapy and 2 years as a clinical study lead / project manager is required;
global clinical trial experience is highly preferred.
in study project management and prior management of contracted resources/CROs
is required; site monitoring and clinical quality compliance experience are
knowledge of Good Clinical Practices and current knowledge of FDA regulations
for IND clinical trials is required; international clinical trial experience
and knowledge of other country regulatory requirements is preferred.
computer skills including proficiency in Work and Excel are required;
experience with PowerPoint and SharePoint is preferred; experience with or
working knowledge of SAS is a plus.
communication skills (oral and written)
â€¢ Ability to
develop and maintain good working relationships at all levels, including during
difficult or challenging circumstances
â€¢ Ability to
work under pressure
operational management with attention to detail and deadlines
to travel up to 20% of time including domestic and international travel
This job description is subject to change at any time.