Connie Schaefer Email & Phone Number

Morrisville, Nc, Us

Boston, Ma, Us

• Manage global clinical research trials for Eli Lilly & Company.• Planned and presented at two international training meetings.• Facilitate study team meetings and cross-functional communication.• Manage interface with third parties, functions and affiliates at the trial level.• Proactively identify and communicate to the team risks that may affect the critical path of the clinical trial and schedule.• Function as primary study contact for affiliates. • Facilitate networking across members of the study team so that effective teamwork and problem solving can occur• Communicate across teams keeping all contacts well informed of timelines, unanticipated issues and solutions and actions for which they are being held accountable.• Proactively ensure documentation is complete for protocol violations, investigator/ERB information, and other elements that are required for clinical study report submission.• Ensured the trial management system was accurate with project milestones.• Author clinical section of Right to Operate documents

Provide project management, site management and data management services for clinical research trials. Collaboratively work with clients to meet timelines and provide quality product. Participate in client meetings contribute ideas for enhanced communications and effective project management/site management. Responsible for identifying new business opportunities, negotiating contracts, and invoicing clients.

Provided day-to-day team leadership and clinical guidance to project teams for assigned projects across a variety of therapeutic areas. Duties included timeline development, protocol/case report form development, general project planning and assessment, fiscal tracking, and resource management. Coordinated activities with team members in multi-departmental environment, including project-assigned physicians. Contributed to quality enhancement programs within the company.

Managed all on-going studies for an investigational drug including; preparing protocols, designing case report forms; assisting in design of quality assurance monitoring; selecting investigators; performing prestudy, study initiation monitoring and study termination visits. Ensured proper execution of study protocol and documented protocol violations.

Bella Vista, New South Wales, Au

• Coordinated two clinical research trials.• Designed case report forms for two clinical trials.• Monitored 35 clinical sites nationwide.

Master'S Degree, Management

Bachelor Of Science (Bs), Biology