PROJECT MANAGEMENT Rossow

PERSONAL PROFILE

  • 20+ years in clinical research, Phases I through IV primarily in US, and some in Canada, Iceland,
    and Eastern and Western Europe

EXPERTISE

Project Management, Clinical Operations, Site Selection, Study Start-Up, Patient Recruitment, CRA, Trial Master Files, Investigators Meetings, Vendor Management, Training and Mentoring.

PROFESSIONAL EXPERIENCE

Independent Consultant – Rossow Consulting LLC.

Manage clinical research projects in therapeutic areas including COPD, hyperlipidemia, hyperphosphatemia, skin/soft tissue infections, bacteremia, oncology (hematologic, colorectal, and pain management), restless legs syndrome, diabetes, urinary incontinence, HIV/AIDS, osteoporosis, psoriasis and psoriatic arthritis, glaucoma, partial epilepsy, gout, and ischemic stroke. Provide services including site selection, patient recruitment, study start-up, trial master files, and vendor management.

Senior Program Manager – ThreeWire Inc.

Responsibilities included developing, implementing, and managing effective strategic solutions across the full range of therapeutic areas for customers as well as oversight of program service areas including: creative services (print and broadcast media development, media planning and buying), call center services using nurse-staffed Patient Interaction Center® (PIC®), and Site Services providing customized site-based services. Made site evaluations and process recommendations. Provided site staff support such as dedicated Enrollment Assistants®.

Senior Clinical Monitoring Manager – Clinical Operations, Sepracor Inc.

Oversaw study start-up and site management activities for multiple protocols in global drug program. Provided site, CRA, and vendor selection, training, and management. Managed investigator meetings. Developed site tools and support systems. Trained and mentored study team during start-up and enrollment. Identified barriers to recruitment and recommended tactical solutions to team. Reviewed study protocols and reviewed and approved all monitoring tools and documents. Mentored and trained entry level CMMs. Led process improvement initiatives.

Senior Clinical Project Manager Clinical Operations and Data Analysis, Sepracor Inc.

Provided clinical leadership to multi-disciplinary team and project budget planning and review. Managed independent contractors. Centralized patient recruitment tactics (surveyed vendors, clinical sites, and internal users; developed a tracker of vendor services and performance metrics) and authored protocols, amendments, and administrative letters. Managed clinical program time lines and deliverables as well as scope of CROs and vendors. Organized / participated in Investigators Meetings, collaborated on key regulatory documents (Investigator Brochures, Annual IND Safety Reports, Clinical Study Reports, etc.), monitored enrollment activity, and coordinated patient recruitment and retention initiatives.

Independent Contractor

Clinical Monitoring Manager, Sepracor Inc.

Clinical Operations Consultant, Enanta Pharmaceuticals

Study Start-Up/Outsourcing, Inotek Pharmaceuticals

Patient Recruitment, Patient Recruitment Strategies LLC