Clinical Development Manager

Company Name:
Clinical Blend, LLC
Clinical Development
- Gaithersburg, MD

Clinical Development Manager responsible for leading a cross-functional operational team to deliver late phase clinical studies to time, cost and appropriate quality.

Leads the delivery of late phase global clinical studies from the study specification to the final clinical study report and archiving
Interfaces with internal or external partners to oversee the delivery of studies and to identify and solve operational issues
Accountable for agreeing with the project team and functions most efficient procedures for delivery
Applies project management techniques to ensure time, cost, quality, and safety standards are achieved
Provide input into study feasibility, study specifications, recruitment plans & determine country participation in Study
Ensure compliance of study with mandatory governance controls such as (Delegation of Authority, Sarbanes Oxley Act, Study attestations, Letter of Assurance, Clinical Trial Disclosure, etc.)
Apply lean sigma and change management techniques to own study & organization

Role requirements
University degree, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
At least 5 years' experience from within the pharmaceutical industry as Clinical Trial Manager or Project Manager.
Good experience in clinical development process in various phases of development and therapy areas
Extensive experience in global clinical operations
Project management certification preferred but not mandatory
Knowledge of process improvement methodology such as Lean Sigma/change management is desirable but not mandatory
Vendor management experience preferred

Skills and Capabilities
Core Capabilities in Project Management, Influencing, Financial/Fiscal Awareness and Supplier/Partnership Management

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