Catharine Christopherson

About Catharine Christopherson

Dedicated, enthusiastic and seasoned Global Study Start Up Associate Director. Proven success in meeting and exceeding project goals including but not limited to study start-up, site feasibility and staff oversight with specific expertise in study start-up and problem-solving. Additional experience and success in managing and mentoring staff and employee career development. Over 24 years experience in clinical research including site, CRO and Pharma roles. Specific skills and attributes include:• MS in Clinical Research• Study start-up and operations management• CRO management• IRB oversight• Feasibility assessment and collaboration• Site budget and contract oversight and management• Study budget management and recognition• Regulatory Authority and IRB strategy and management• Supervision, mentoring and career development of groups• Problem-solving and process improvement specialist• Decisive leader for escalation pathway processes• Expert in planning and organizing daily, weekly and monthly tasks • Experienced Informed Consent reviewer, writer and negotiator• Experienced regulatory document reviewer• Document tracking management and compliance• Knowledge and adherence to Federal regulations, ICH guidelines and GCPs• Internal site file auditing experience• Relationship development• Energetic professional focused on finding cures and treatment for patients.

Experience

1. Associate Director, Global Study Start up Lead

   AbbVie

   May 2023 — Present

   Providing start up focused strategic input on the study plan, country strategy, start up timelines, site profiles and risk assessments for their assigned TA and/or Indication• Establishing global activation plans in partnership with Area Study Start Up Leads (ASULs) and the Primary Site Monitors (PSMs), including risk assessments and mitigation planning• Driving alignment with Clinical Trial Submissions and Regulatory on global submission strategy to assure coordination with EC submissions, contract execution and activation planning• Driving standardization in global start-up process and training, including sharing of best practices and lessons learned• Monitoring start up progress against established Start Up KPIs and Milestones• Overseeing ASULs and Country Study Start Up Specialist from an operational perspective for their assigned trials or programs• Partnering with Clinical Study Leadership and Clinical Site Management TA Leads to facilitate cross-functional communication and collaboration• Supporting the development and maintenance of SOPs, tools, and templates for study start up activities• Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines• Participating in or leading process improvement initiatives

Education

• Campbell University

  MS, Clinical Research

• North Carolina State University

  BS, Biology, minor in Genetics

Skills

• Clinical Research
• Ich-Gcp
• Regulatory Submissions
• CRO
• Standard Operating Procedure (Sop)
• CRO Management
• Regulatory Affairs
• Clinical Development
• Ctms
• Oncology
• Protocol
• Management
• Biotechnology
• Gcp
• Pharmaceutical Industry
• Sop
• Good Clinical Practice (Gcp)
• Internal Audit
• Clinical Trials