Clinical Project Manager
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POST DATE 9/17/2016
END DATE 10/18/2016
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.
Manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met.
Manage study-related vendors; identifying potential risks and resolving issues; establishing vendor oversight plans and reviewing quality metrics.
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.
Review 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.
Ensure 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.
Perform and/or oversee site initiation, monitoring and/or close out visits for clinical trials as needed.
Coordinate the negotiation of site budgets within guidelines, and provide oversight for the site payments per contracts.
Facilitate site study drug orders and ensuring site accountability records are maintained.
Provide 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.
Participate 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 agencies.
Organise, present at and participate in investigator meetings, project team meetings other study trainings and meetings as required.
Support vendor selection processes as required.
Act as mentor and co-monitor with less senior CRAs and CTAs to ensure high quality as required.