Shannon Cunningham

Accountable for strategic and operational management and successful country execution of all phases of clinical trials within the Oncology-Solid Tumor Therapeutic Area

• Resource allocations
• Adherence to timelines and budgets
• Compliance with Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements

Support the Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency and effective issue management

Responsible for line management of Local Trial Managers(LTMs) and Site Managers (SMs)

• Oversee staff performance, development, training, project assignments, workload distribution and support issue resolution (staff size 25)
• Established performance goals for employees and provided feedback on methods for reaching those milestones
• Evaluated employee performance and conveyed constructive feedback to improve skills
• Assisted in organizing and overseeing assignments to drive operational excellence
• Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement

Ensure alignment of local goals with organizational objectives

Drive innovative solutions and process improvements for Oncology - Solid Tumor trials in the USA

Responsible for the local management of clinical trials in the USA

• Primary point of contact at country level for Infectious Disease and Vaccine Studies
• Operational oversight of assigned protocols from pre-feasibility through database lock and closeout activities
• Responsible for coordinating and leading local trial team to deliver quality data and trial documents/records that are compliant with assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements

-Gained strong leadership skills by managing projects from start to finish.

-Demonstrated strong organizational and time management skills while managing multiple projects.

-Skilled at working independently and collaboratively in a team environment.

-Participated in team projects, demonstrating an ability to work collaboratively and effectively.

-Contribute to process improvement; training and mentoring of LTM colleagues

Responsible for the local management of clinical trials in the USA

• Primary point of contact at country level for Infectious Disease and Vaccine Studies
• Operational oversight of assigned protocols from pre-feasibility through database lock and closeout activities
• Responsible for coordinating and leading local trial team to deliver quality data and trial documents/records that are compliant with assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements

-Organized and detail-oriented with strong work ethic.

-Cultivated interpersonal skills by building positive relationships with others.

-Managed time efficiently in order to complete all tasks within deadlines.

-Excellent communication skills, both verbal and written.

-Developed strong communication and organizational skills through working on group projects.

-Learned and adapted quickly to new technology and software applications.

Responsible for the local management of clinical trials in the USA

• Primary point of contact at country level for Infectious Disease and Vaccine Studies
• Operational oversight of assigned protocols from pre-feasibility through database lock and closeout activities
• Responsible for coordinating and leading local trial team to deliver quality data and trial documents/records that are compliant with assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements

-Excellent communication skills, both verbal and written

-Worked well in a team setting, providing support and guidance

-Used critical thinking to break down problems, evaluate solutions and make decisions

-Adaptable and proficient in learning new concepts quickly and efficiently

Support operational aspects of all GCDO managed trials, both internally managed and outsourced trials, with variation across all phases of a trials (planning, start-up, execution, data analysis, reporting and closure)

• Provide support of trial team (Global Program Lead, Global Trial Lead)
• Track trial progress towards planned milestones, as well as related progress analysis and follow-up, track trial and country budgets and support invoice reconciliation
• Support protocol feasibility and vendor set-up
• Perform trial specific system set-up and access management, system data entry

-Internal and external meeting planning, coordination, outcome documentation and related follow-up

-Strengthened communication skills through regular interactions with others

-Participated in team projects, demonstrating ability to work collaboratively and effectively

-Cultivated interpersonal skills by building positive relationships with others

-Demonstrated respect, friendliness and willingness to help wherever needed