Catherine K. Email & Phone Number

Collegeville, PA, US

Woonsocket, RI, US

Princeton, New Jersey, US

On assignment at Novartis

Warrington, PA, US

Warrington, PA, US

- Select, engage, and manage contract research organizations (CROs) and other contractors supporting the Company’s Global clinical trials;- Collaborate with Clinical Research, Biostatistics, and Regulatory Affairs in the planning of clinical studies, development of study protocols, and related activities and documents;- Collaborate with Manufacturing and.

• Responsible for setting up and overseeing Functional Service Provider Model
• Ensured delivery of clinical study outputs that meet and exceed established quality, schedule and budget expectations
• Ensured operational excellence and integrity through adherence with Sponsor policies and procedures, GCP, ICH, FDA and all other international regulatory requirements
• Managed cross-functional team and ensure adherence to study timelines in collaboration with study team; report progress and timeline deviations and manage stakeholders
• Proactively identified project risks and develop plans to mitigate them
• Assisted with protocol design, consult on operational/logistic issues and ensure all operational aspects of the clinical trial are satisfactorily addressed

Melbourne, Victoria, AU

Global position within site management providing central and comprehensive oversight and coordination of operational capabilities and systems associated with site management, monitoring and monitoring oversight across all programs and geographic regions. Accountable for the monitoring and monitoring oversight strategy, including the development and.

Melbourne, Victoria, AU

• Ensure that clinical programs are successfully planned, implemented and completed in accordance with the Company strategy as well as within the agreed timeframe and budget
• Build and lead a dedicated clinical operations team within the Americas.
• Oversee internal and insourced regional site management staff and ensures a strategic relationship with the CROs within the Americas.
• Primary interface with the CSL Commercial Operations organization in the designated region and works closely with other functional heads to ensure global consistency.
• Provide regional input into the design of clinical program(s) as well as clinical operations study documents

Paris, France, FR

In addition to the Clinical Monitoring Management responsibilities listed below: Responsible for the oversight and maintenance of US Regional Monitoring Partnership with RPS Responsibilities include, but not limited to are: Vendor Management Ensuring proper resourcing and utilization of all roles: CRA, PM, Managers, Training and Regulatory (100+.

Paris, France, FR

- Responsible for the management and development of the Clinical Trial Managers (CTM) - Ensures all trials are conducted in line with appropriate standards and Sanofi Pasteur SOPs, and maintains the development of CTMs in monitoring skills- Responsible for hiring and commencing appraisals of CTMs- Provide growth and development opportunities for CTMs- Led.

Brentford, Middlesex, GB

- Monitoring Manager Point of Contact for the Global TPO Trials (Oncology)- Responsible for management of 11 full time employees- Assess CRA workloads and assign sites to CRAs in a timely fashion to ensure effective utilization of staff. - Adjust and balance workload across all CRAs- Responsible for conducting CRA performance Reviews & promotion.

Brentford, Middlesex, GB

• Senior Clinical Research Associate March 25 2002 – 28 Feb 2005GlaxoSmithKline Pharmaceuticals Collegeville, PAIn addition to monitoring responsibilities noted:
• Certified Local Trainer
• Manage regionally based activities (e.g. coordinate and advise monitoring staff, including contract monitors, etc.) as delegated by Regional Monitoring Manager.
• NE Representative on National CRA Governance Team – 2002 - 2003
• Mentor/Train and manage day to day activities of assigned new employees
• Committee Member – Revolutionizing Patient Recruitment & Embedding Patient Recruitment - 2003

Brentford, Middlesex, GB

- Supervised multiple Contract CRA’s assisting with monitoring responsibilities.- Monitor Liaison/Lead CRA on multiple study protocols i.e. HPV 999910/106, HPV 580299/001, ETEC 238879, Havrix 208109/210, Pentavalent 217744/084 and 217744/085.- Involved in protocol and Remote Data Management training of CRAs- Successfully monitored and managed multiple.

• Responsible for hiring, managing and supervising all activities of the Clinical Studies Associate (CSA), Administrative Assistant and temporary support personnel.
• Responsible for Interview Process
• Responsible for Hiring
• Conduct Performance Reviews
• US Clinical Monitoring Team representative on all Phase I - IV protocol and Clinical Trial Supplies teams
• Involved in assisting Therapeutic Areas with CRO Management on studies contracted out.

 Supervision of Topotecan (Oncology) DM Team  Clinical Data Coordinator Lead who was solely responsible for all phases of global RSV Clinical studies protocols from inception to end phases of this study - Responsibilities included supervision of 12 member team Review Case Report Forms (CRF), associated documents and DRQ replies of specific compounds to.

Bsn, Nursing

Masters (In Progress), Quality Assurance & Regulatory Affairs