On Site position- Clinical Research Global Studies Leader - New York City 10016
Industry: Pharmaceutical Research & Early Development
Core skills: Study Management, Clinical Studies
Job Primary Responsibilities and Accountabilities:
- 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
- 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
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.
Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or public
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
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