Heather Lohse Email & Phone Number

Vernon Hills, Il, Us

Acts as primary liaison between ProPharma Group and the Client to ensure project launch, conduct, and closeout according to the Client's and the ProPharma Group contractual agreement.•Leads clinical team to ensure quality, timelines, and budget management.•Accountable for the financial performance of assigned projects.•Accountable for all project deliverables for assigned projects and/or project regions.•Coordinates activities and deliverables of all project conduct partners and proactively identifies and managesissues.•Accountable for maintenance of project information on a variety of databases and systems.•Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.•Responsible for project management components of inspection readiness for all aspects of the project conduct,including Trial Master Files.•Provides oversight for development and implementation of project plans in accordance with project specificrequirements, regulatory requirements, and SOPs.•Independently prepares, coordinates, and presents project material at internal and external meetings.•Directs the activities of assigned Project Support staff; line manages, and mentors other project managementteam members and clinical staff as assigned while facilitating teambuilding and communication.•Prepares project management reports for clients and management.•Implements resource strategies to achieve project goals.

Clinical Study Management of Lero studies; Senior Study Management of Phase 3 TNBC; Project Management of Trila program.

Solutions-driven Senior Clinical Project Manager with a history of success maintaining regulatory compliance and coordinating trials from conception to completion for phases FIH, I, II, III, IV for over 50 studies, including Humira, SKYRIZI, RINVOQ, and Vicodin. Extensive expertise in medical jargon, terminology, and therapeutic areas including immunology (Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis), Pain Therapeutics, and Oncology. Capable of effectively managing multiple timelines and activities simultaneously, including study milestones, regulatory, monitoring, legal assignment agreements, vendors, site interaction, contracts/amendments, data analysis, and payments. Expert in networking cross functionally between Compliance, Finance, Outsourcing, Vendor Management, Data Sciences, Meeting Planning teams and senior leadership to achieve program goals.Special Career Highlights:● Directed an enterprise-level initiative to optimize PRO/COA (Patient Reported Outcomes/ Clinical Reported Outcomes) business practices to align with the upcoming EUCTR directive requirements.● Recognized repeatedly for strategic decision making to meet/ exceed high-profile study milestones.● Led transition of Legacy Allergan (L-AGN) studies into AbbVie PRO/COA processes for PRO/ePRO study startup, training and working with teams on an individual basis to ensure smooth process deployment.● Extensive experience with employee management, training, and development.● Managed on-the-ground research including a Phase Ill, breast cancer study exploring the sequence and combination of adjuvant docetaxel in high-risk women. This required monitoring 11 sites and over 400 subjects in Switzerland, Slovenia, Sweden, Spain, and Italy.

Bachelor Of Applied Science (Basc)

Associate'S Degree