Study Manager

Major Responsibilities：

• Leads the cross-functional Study Management Team (SMT) for ED&CP studies.  The SM is responsible for the planning, communication, motivation and direction of the SMT, including obtaining agreement on project required timelines, study objectives and goal-setting
• Prepares and manages the budget/financial plan including overall study cost, contract negotiations and preparation, payment schedule and tracking
• Identifies key milestones and tracks critical study activities, issues and strategic priorities and provide regular updates as appropriate.
• Ensure, with SMT partners, the development of study protocols, case report forms (CRFs) and necessary regulatory documentation following the provision of clear objectives. The study manager is accountable for the creation of the final protocol based on the synopsis provided by the Translational Medicine Leader(TML), Clinical Pharmacologist (CP) or Bio-marker Leader (BML).
• Conducts protocol and site feasibility assessments to ensure optimal site selection
• Performs all aspects of study management including supply 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
• Proactive management of all clinical samples to ensure high quality.
• Manages both internal and external partners
• Assures consistency and standards across a study or studies for all investigational sites and in line with project standards
• Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality
• Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs
• Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
• Networks and shares best practices with colleagues to ensure optimal efficiency and consistency in Roche study management.
• Provides support and mentoring to other SMs, SMAs and CSAs

Requirement：

• Bachelors (or Masters) degree or equivalent in a biomedical or life sciences discipline
• 3 + years study management experience in clinical or pharmaceutical development
• Working knowledge of international regulatory and ICH GCP guidelines