Kelly Services Clinical Research Global Study Leader- New York City in New York, New York
Clinical Research- Global Studies Leader- New York City 10016 (near Bellevue Hospital)
Leads the cross-functional Study Management Team SMT. In the SMTL role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking Identifies key milestones and tracks critical study activities, issues and strategic priorities.
Provides regular updates as appropriate, to key stakeholders. With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms CRFs with Data Management, and necessary regulatory documentation following the provision of clear objectives. Conducts protocol and site feasibility assessments to ensure optimal site selection 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
Proactive management of all aspects of the study Manages both internal and external partners For outsourced studies, 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 lifecycle 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 CRSLII may provide support and mentoring to other CRSLs. Where appropriate, accountable to DBPT for planning, tracking and managing the operational budget, resources and timelines for the project against the agreed goals of the team.
Strong leaderships and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies Demonstrated consistent achievement of team delivery against commitments and goals. Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans.
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AboutKelly Services ®
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