Douglas Bennett
- Role
- Global Clinical Research Study Lead at Roche
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Douglas Bennett
Energetic and progressive professional with robust experience in Clinical Project…
Experience
Global Clinical Research Study Lead
Jun 2016 — Present
Proactively leads Study Management team consisting of all core functional areas (Safety, Clin Pharm, DM, Biostat, CRO representatives, CRA, Programmers etc.) from business initiation of project through final CSR and financial closeout With study team partners, ensures the development of study protocols, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives. Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines Contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study Utilizes clinical project management methods to ensure streamlined team communication, accurate and concise metric reporting, clinical planning for all study milestones, vendor and external partner oversight, internal liaising, and financial forecasting/budget management Identifies and develops study team goals (e.g. study milestone timing or data delivery expectations) and ensure successful completion of goals Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
Skills
- Fda
- Electronic Data Capture (Edc)
- Ctms
- Clinical Study Design
- Good Clinical Practice (Gcp)
- Clinical Research
- Edc
- Therapeutic Areas
- Healthcare
- Clinical Development
- Sop
- CRO
- Irb
- Protocol
- CRO Management
- Gcp
- Clinical Monitoring
- Clinical Trials
- Data Management
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