Anne Connor Email and Phone Number

I currently serve in dual roles as a Clinical Investigational Lead (CIL) and Operational & Science Lead (OSL) for multiple oncology Phase I-IV compounds. I drive development of the study protocol, informed consents, study procedures manual, clinical dossiers, and annual reports. I also lead clinical operations including site initiation, recruitment, drug supply management, query resolutions, toxicity management, and human biological sample management across multiple time zones and 19 countries. It is my responsibility to ensure clinical trials are conducted in compliance with State and Federal regulations, Good Clinical Practice regulations, and internal SOPs. I lead all risk management efforts; collaborate with key external experts, cultivate solid relationships with ARO collaborators, and lead teams through inspection readiness.Key Contributions:• Led team in delivering highest-quality data and documentation including CTR, CSR, and FDAAA and manuscript on time as CIL for major Tyverb randomized Phase III trial.• Served as OSL for largest, most complex Phase III oncology trial in company history; played key role in delivering DBR, DBF, and SAC on-time, despite multiple challenges.• Delivered Tyverb EU DFS SCS Type II variation submission 2 weeks earlier than deadline by proactively identifying gaps in submission process and devising efficient solutions.• Played key role on cross-functional team that developed Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and Clinical Overview (CO).• Honored with “Recognition Award” for successfully leading Tykerb + Paclitaxel wave 3 submission and generation of China-specific submission document.• Recognized with “Recognition Award” for integral leadership role in delivering ALTTO DBR, DBF, and SAC on-time and delivering retrospective due diligence buyer survey for trial.• Awarded “Recognition Award” for contribution to Tykerb on two Type 2 submissions: CNS and AI.

During this timeframe, I performed as a Global Study Manager and Operational Study Lead for Tykerb breast cancer studies. I assumed full accountability for all study functions and activities. Key Contributions:• Established and fostered solid relationships with trial sites to enable optimal trial guidance.• Evaluated study protocols for tangible clinical objectives and operational efficiency.• Monitored performance of CROs; led Regional Clinical Operations teams to on-time study delivery.• Developed and administered study budgets, established timelines, and responded to patient and site inquiries. • Ensured audit-readiness of all studies.

As a Senior Clinical Data Scientist, I drove Phase I-IV Oncology trials from study set-up phase through database lock.Key Contributions:• Defined and developed Oncology standards from CRF/eCRF creation through reporting as Data Management representative for Oncology Therapeutic Standards Team.• Developed training materials and facilitated training for new-hires and less experienced CDSs on Oncology processes, including RECIST solid tumor response criteria.• Led CDS for two studies that supported FDA/MHRA submission of Tykerb.• Developed Clinical Dossier Specifications for first-ever Tykerb trial utilizing InForm.

In my earliest GSK role, I managed Phase I-IV compounds from study set-up through database lock.Key Contributions:• Reviewed and validated case report forms, managed data queries, and ensured data integrity.• Evaluated clinical data to identify inconsistencies with departmental and protocol specific guidelines.