- Key leader for implementation of clinical validation plans that support the Life Cycle Team #8211; Virology
- Key support person for Clinical Operations Lead for the Life Cycle team (Virology).
- Works closely with the Director of Clinical Research and Director of Scientific Affairs as part of the Clinical Research Implementation Team.
- Plans, implements and executes registration trials (e.g. FDA) to support clinical claims as well as claim expansion of products for RMS; also plans, implements and executes additional post-launch clinical trials of CE-marked and FDA approved/cleared products.
- Works independently and is highly autonomous.
- Represents the department at cross functional project teams and business unit level.
- Serves as subject matter expert with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
- Fully accountable for the results and achievements of assigned projects.
- Regularly interacts with Medical & Scientific Affairs management on work of area(s) that impacts larger organizational goals.
- Implements global study support strategies and initiatives.
- Supports the preparation of reports and summary documents (for internal and external customers) for product registration and publications.
- Supports Clinical Research lead by executing budget and contract negotiations with study sites, central laboratories and CROs.
- Prepares and tracks study budgets and resource allocations.
- Supervises the study start-up, monitoring and study close-out activities being performed within the team.
- Ensures adherence to regulations, guidelines and departmental standard operating procedures on the part of direct reports and monitors the trial budgets and timelines.
- Maintains a high level of professional expertise through familiarity with scientific literature, Roche product portfolio and competitive environment. Represents RMS in hospitals and labs and interacts with international opinion leaders in the field of NAT, investigators and other key customers.
- Plans and prepares execution of studies through all phases of the study process.
- Provides technical input to study designs and clinical development plans.
- Reviews study proposals, clinical plans, clinical study protocols and reports, publication strategies and manuscripts.
- Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
- Supervises, coaches and trains Clinical Research Monitors, CRAs, Senior CRAs and/or Principal CRAs, and conducts performance reviews and feedback discussions. Implements and monitors development plans with direct reports.
- Negotiates proposals and manages outsourcing services and resources from Contract Service Providers (e.g. CROs, and Outsourcing Providers).
- Ensures compliance of direct reports with Study Protocols, Good Clinical Practices, Good Documentation Practices, regulations, SOPs, and company policies and guidelines.
- Collects and maintains legal and regulatory documentation, as applicable.
- Ensures accurate and complete study management/data collection and transfer into the data management system.
- Ensures clinical trial site compliance with regulations and study protocols.
- Acquires and maintains technical knowledge of product line.
BioSpace.com - 16 months ago
Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...