CyberCoders Clinical Trial Manager in Cambridge, Massachusetts
Clinical Trial Manager Clinical Trial Manager - Skills Required - Clinical Trial Manager, Study Management, ICH, GCP, Timeline Development, Budget Management, Vendor Management, Clinical Systems, Clinical Regulatory Documents, Ophthalmology/Hematology/Rare Diseases
If you are a Clinical Trial Manager with experience, please read on!
What You Will Be Doing
The Clinical Trial Manager is accountable for the management of one or more clinical trials including trial start-up, conduct, and close-out activities.
Leads one or more Study Management Teams
Ensures trial adherence to ICH/GCP/local regulations
Develops the study plan(s) including key milestones and timelines
Ensures country and site selection meet study requirements
Develops and manages clinical trial budgets
Ensures accuracy and timeliness of vendor and site payments
Vendor identification and management (e.g., CROs, IVRS, Reading Centers, etc), including participating in negotiation of vendor scope of work, budgets, performance management, issue resolution, and quality assessments
Ensures availability of clinical/non-clinical supplies
Provides input to clinical regulatory documents (IB, CSR, IND updates)
Participates in the development and testing of clinical systems (laboratory, data entry, IVRS, etc)
Ensures internal and external systems are updated timely (CTMS, clinicaltrials.gov)
Maintains or oversees the maintenance of the Trial Master File
Author/co-author protocol in collaboration with Medical Monitor and other stakeholders
Identify, address and communicate quality and compliance concerns
Ensures inspection readiness internally and externally
Provides regular study status updates and as requested
Communicates effectively with internal and external study personnel (investigative staff, vendors, etc)
Provides study-specific direction, mentoring and management to other staff as appropriate
Manages direct reports as assigned
What You Need for this Position
Bachelors Degree with a minimum of 4 years of clinical research experience
Knowledge of GCP and ICH
Experience in ophthalmology, hematology, or rare diseases preferred
Experience developing study plans and budgets including risk mitigation strategies
Experience in multiple phases of research preferred
Effective written and verbal communication skills
Proficient computer skills
Ability to travel
So, if you are a Clinical Trial Manager with experience, please apply today!
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Clinical Trial Manager MA-Cambridge NN1-1366638