Clinical Project Manager
US$150000 - US$170000 per annum
11 maanden geleden
Study document generation, including Protocol, Informed Consent Forms, CRFs, Monitoring Guidelines, etc. and in depth review of and contribution to study-specific documents from other functional areas (e.g. data cleaning plans, statistical analysis plans, vendor contracts, etc)
Study specific training to both internal and external team members
Create and manage a cross-functional study team and lead study team members
Ensure adequate participation, contribution and accountability of the clinical study team members in adherence with applicable SOPs and processes
Study timeline negotiation and management
Ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner
Vendor oversight including selection, management and quality assurance, especially of monitoring and study management vendors, but also of other area vendors (e.g central laboratories, IVRS, etc), in collaboration with study team members
Budget management to ensure that the budget appropriately meets the needs of the study, while maintaining cost controls
Timeline management including the definition, updating and transmittal of the status and planning of the study
Ensure CSR generation through the medical writing group, including participation in the discussions and decisions regarding data structure, design, interpretation, analysis, and summarization of clinical trial data
Identification, evaluation and selection of clinical investigators
Represent the clinical study team to clinical investigators, vendors, and consultants.
Accurately and efficiently work toward quality results, creation of new processes and procedures, and decision-making based on precedent, company policies, federal regulations, and Good Clinical Practice
BS or BA degree, preferably with a scientific basis
Minimum 2 years of experience independently managing Phase II or III studies with a sponsor or other CRO
Experience with direct management of personnel
Protocol generation of multiple phase II or III clinical study protocols is preferred.
Working knowledge of federal regulations and Good Clinical Practice
Ability to look at a project from budget, timeline, and quality perspective and correctly prioritize rectification if/when needed
Ability to engage and demonstrate cooperative behavior to support team efforts
Experience in responding rapidly to changing priorities and in managing aggressive deadlines
Desire to understand the business beyond the project management function with a deep sense of personal responsibility and a "team" mentality.
Technology: Advanced knowledge of Office 365 suite including excel and powerpoint is the minimum acceptable. Prefer highly technical CPMs who stay current on technology trends within the industry.
Ability to travel, both domestically and internationally - International travel will be minimal