Consultant, Clinical Trial Project Manager, Pharmaceutical
Summary
Our client is a pioneering organization dedicated to conducting clinical trials focused on Central Nervous System (CNS) diseases who is committed to advancing medical research and improving the lives of patients affected by CNS disorders. Their collaborative approach involves working closely with a Contract Research Organization (CRO) and other partners to ensure the successful execution of clinical trials.
Position Overview:
We are seeking a motivated and experienced Clinical Trial Project Manager to join our team remotely. The ideal candidate will be responsible for independently providing support for day-to-day clinical study activities under the supervision of Clinical Trial Leadership with Leadership providing study-specific expertise.
Duties / Expectations of Role
Study Start-Up Activities:
· Assists the study team(s) to deliver the clinical study within agreed timelines.
· Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors (e.g., Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
· Provides oversight of Clinical CRO Investigator background checks.
· Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.
· Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
· Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
· Manages escalation of study related issues and communicates as appropriate with Clinical Operations Manager.
· Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System.
· Assists and/or participates in planning and conducting Investigator Meetings as necessary.
Study Maintenance Activities:
· Assists Clinical Operations Manager in tracking study activities which are not appropriate to be outsourced.
· Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Operations Manager.
· Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
· Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.
· Assists with oversight of Clinical CRO activities regarding amendments to country and site specific informed consent documentation tracking, finalization and approval.
Study Close Out Activities:
· Assists study team with preparation for audits/inspections
· Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Operations Manager.
· Liaises with Transparency group to ensure Clinicaltrials.gov and results are updated accordingly. 10%
· Departmental Tasks:
· Maintains knowledge for related systems and processes.
· Maintains up-to-date training record attending internal/external training(s) as necessary.
Mandatory Requirements
· At least 3-5 year's experience in similar/relevant job (e.g., Sponsor, CRO, or Clinical Study Vendor)
· Ability to work independently and take initiative
· Relevant experience in clinical research or related field
· Adequate Good Clinical Practice training
· General knowledge of regulatory requirements and guidelines governing clinical research
· Must be able to work in a fast paced environment
· Demonstrate ability to prioritize multiple competing tasks
· Ability to work with minimal supervision and complete tasks according to deadlines
Term & Start
· 12+ month contract
· Full time (40hrs/week); benefits included – health, dental, vision, 401k
· Some overtime may be required
· 100% Remote
Pay Range: 65-75/hr