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