Theresa C. Hively

About Theresa C. Hively

Currently have over 15 years experience in clinical research. Experience includes 4 years…

Experience

1. Clinical Lead (Oncology)

   IQVIA

   Jul 2021 — Present

   Manage operational aspects of projects to support right subjects and data to meet or contractual requirements. Collaborate with project leader and LCA to establish an integrated set of plans with Clinical Lead to be ultimately accountable for results of clinical team. Represent clinical delivery with customer.* Produce and distribute status, tracking and financial reports for core project team, other functional groups and senior management.* Responsible for tracking financial deliverables, reporting and invoicing projects.* Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer. Ensure Site Recruitment Action Plan, patient recruitment target and contingency plans are in place and deployed at trigger points.* Deliver project / program according to quality management plan. Guide CRAs and advise on critical specific study issues.* Manage clinical set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums.* Accountable for approving final site lists.*Develop risk management plan from clinical perspective and coordinate clinical issue escalation and resolution with Project Leader.* Collaborate with other functional groups such as Global Delivery Network, Labs, Data Management, Pharmacovigilence, and Biostatistics to support milestone achievement and manage study issues and obstacles.* Provide ongoing training and support to clinical team. Conduct frequent team meetings and ensure regular communication.* Drive high performance and efficiency of clinical team through CRA project objectives, conduct of monitoring visits. Provide performance feedback to management on clinical team members.* Utilize appropriate tools, processes and GDN for study team to support the execution of clinical deliverable and study timelines.

Skills

• Clinical Development
• Informed Consent
• Therapeutic Areas
• Drug Development
• Patient Recruitment
• Institutional Review Board (Irb)
• Research
• Lifesciences
• Clinical Study Design
• Clinical Research Associates
• Hematology
• Drug Safety
• Regulatory Affairs
• Good Clinical Practice (Gcp)
• Regulatory Submissions
• Healthcare
• Medical Research
• Clinical Data Management
• Ich-Gcp
• Oncology Clinical Research
• Gcp
• Healthcare Management
• Edc
• Fda
• Clinical Trials
• Regulatory Guidelines
• Study Coordination
• Cancer
• Sop
• Medical Writing
• Data Management
• Standard Operating Procedure (Sop)
• Ctms
• Clinical Monitoring
• Irb
• Oncology
• Clinical Research
• Protocol