Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Global Trial Manager

  • Jun 2007 - Present

• Sr. Trial Manager

  • Jun 2007 - Present



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Operations Specialist

  • Oct 2006 - May 2007

  • Primary Member of a cross-functional clinical trial team involved with the clinical development of Zolinza program. Specifically responsible for trial level management of a Phase I study on patients with acute myelogenous leukemia or myelodysplastic syndrome• Single point of contact for internal and external customers.• Responsible for the Clinical Operations Plan – an agreement among the CTT with regards to milestones, risks and risk mitigation strategies, recruitment strategies, clinical and ancillary supplies, shared team objectives.• Tracked and monitored study metrics, specifically site ready deliverables and enrollment.• Worked closely with the Program Clinical Operations Specialist to identify, resolve and/or escalate issues. Identified and implemented strategies to improve productivity at the site level. • Plan and coordinate activities with internal clinical and other functional teams and meeting planners for Investigator's meetings. Show less

• Lead Medical Program Clinical Specialist

  • Nov 2004 - Sep 2006

  • Authored and developed several Ph I, 3+3, to Ph III adaptive-design clinical trial protocols and amendments, ISS section of the WMA, SAE narratives, risk profiles, informed consent forms, and root cause analysis. Reviewed and approved related study documents, recruitment plan, risk management plan, safety monitoring and management plan.• Served as Lead MPCS for a Phase I combination therapy trial with advanced solid tumors responsible for management and oversight of CRO activities; reviewed, negotiated study contracts and scope changes; coordinated meeting activities and developed agendas and presentations for quarterly meeting with CRO project team and executive management; lead weekly team meetings; facilitated regular safety calls with investigators.• Assisted with design of CRFs, clinical database, and query package. Assisted with authoring the data handling guidelines and data management and monitoring plan.• Determined and finalized drug packaging and shipments. • Planned, organized, coordinated, prepared, and provided face to face training on protocol specific tests and procedures for internal and external customers. • Tracked enrollment, serious adverse experiences, and study-related issues. Reconciled safety and clinical databases.• Provided clinical support on a Phase IIb/III worldwide trial in Mesothelioma and another in DLBCL; reviewed, negotiated, and approved vendor contracts and agreements; served as primary contact for central labs; assisted in design of operations manuals; liaised between sites and vendors; ordered supplies and provided assistance with re-supply to sites.• Assisted with planning of an Investigator’s Meeting and served as presenter. Designed, prepared, reviewed and approved agenda and contents for meeting binders. Assisted with coordination and facilitation of the meeting. Show less

• Associate Medical Program Clinical Specialist

  • Jun 2004 - Oct 2004

  • Managed and monitored site activities for multiple sites on a worldwide, multicenter, prostate cancer prevention mega-trial; tracked enrollment; planned and discussed recruitment strategies with poor-performance sites; implemented risk mitigation plans; generated and issued sponsor consultations and protocol deviations as necessary; maintained and recorded site communications in CTMS.• Performed medical data review, issued and resolved DCFs.• Worked closely and collaboratively with the clinical team and Clinical Monitors in all aspects of the trial.• Participated as a presenter/speaker at Investigator’s Meetings.• Liaised between Merck and external vendors. Show less