Lorena K. Email & Phone Number

Remote, California

United States

Project Management for Early Stage Oncology Development. Responsible for asset life cycle and portfolio project management.

Remote

• Provide vendor and study management for two separate clinical studies, including site initiation, interim and closeout study phases, drafting and developing protocols and informed consent forms, data collection.
• Manage and lead CRO deliverables for global study milestones, track budgets and timelines for multiple vendors, and train study vendors. Track regulatory submissions and manage feedback for regulatory authorities.
• Monitor… Show more Provide vendor and study management for two separate clinical studies, including site initiation, interim and closeout study phases, drafting and developing protocols and informed consent forms, data.
• Monitor study metrics (enrollment, collection of CRFs, resolution of PD, etc.). Provide status reports to management and recommend improvements to study quality, data collection, and communication processes.
• Create and execute study processes, including deviation planning, CRF development, IWRS implementation, site and CRA training development, IM planning, vendor and bid/award process. Assess overall quality assessment.

• Monitored progress of Merck Oncology Phase I - III clinical studies at investigative sites and remotely; ensured clinical trials were conducted, recorded, and reported in accordance with protocol, SOPs, ICH-GCP, and.
• Evaluated, initiated, closed, and monitored trials. Ensured sponsor obligations were observed, timely collection and management of study data and query response, and timelines were met.
• Assessed qualification of potential investigative sites… Show more Monitored progress of Merck Oncology Phase I - III clinical studies at investigative sites and remotely; ensured clinical trials were conducted.
• Assessed qualification of potential investigative sites, including IP accountability, dispensation, and compliance; served as main contact for investigative sites and in-house study team.
• Mentored junior-level CRAs and served as a resource/ subject matter expert (SME) for new employees. Show less

• Lead CRA:Held responsibility for timelines and quality for assigned clinical trials from feasibility assessments, deliverables and training, and CRAs. Primary point of contact between local Study Team and field-based.
• Evaluated and provided input on protocol amendments, process documents, and recruitment material.
• Co-monitored CRAs; managed training and assessed performance… Show more Lead CRA:Held responsibility for timelines and quality for assigned clinical trials from feasibility assessments, deliverables and training, and.
• Co-monitored CRAs; managed training and assessed performance. Ensured CRAs were up to date on study information, timelines, and action items.Key Successes— Developed operations component of Site Initiation Slide Deck.
• Accountable for territory development, site selection, and qualification; managed study data and timelines for all site activities. Ensured compliance with local regulatory requirements.
• Trained study managers on TMF filling and system; conducted training on site management, EDC, and ICH-GCP.Key Successes— Piloted Study Start-Up and Feasibility Program; cultivated strong relationships with key thought.

Managed clinical trial portfolios for the departments of Anesthesia, Gastroenterology, Nephrology, Oncology, Immunology, and Obstetrics/Gynecology, including IRB submissions, contract and budget negotiation. Interpreted sponsor protocols and confirmed feasibility for studies for assigned departments. Established and led process manager working group.

Master Of Business Administration - Mba, Business Administration, Management And Operations

STEM designated MBA

M.S., Health Care Administration

Bachelor Of Arts (B.A.), Geography

Ccra