Project Manager Management

Carl Frederick Lipp IV

*** ******* **, ****** ** 80204 970-***-**** ********@*****.***

EDUCATION

Colorado State University, Fort Collins, CO December 2015 Bachelor of Science in Health and Exercise Science EXPERIENCE

Zimmer Biomet Senior Clinical Operations Project Manager Sept 2022 – March 2025

• Spearhead the development of case report forms, contract negotiations, site recruitment, and support program management for comprehensive project reviews.

• Assist in clinical strategy, the development of study plans, and project deliverables

• Responsible for case report form development, contract negotiation, site recruitment, and support program management for project reviews.

• Establish relationships with outside vendors, medical consultants and partners.

• Provide IND/IDE and NDA summary reports, interface with interdisciplinary teams, monitor project timelines, and develop project management tools.

• Facilitate in the site selection process

• Manage clinical study timelines and budget by utilizing project management tools.

• Responsible for selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines

• Provide Project Presentations and reports

• Facilitate data monitoring and analysis

• Facilitate development of clinical execution strategy

• Overseeing compliance to study requirements

Medtronic Clinical Project Coordinator II, Medical Surgical May 2020 – Sept 2022

• Oversee, design, plan and develop document management and study training plans for studies

• Develop, implement and administrate program/system guidelines and procedures for sponsored, external and collaborative clinical studies

• Create and finalize project related documentation and maintenance within clinical study management systems and records management

• Communicate with study sites and principal investigators to request and document clinical study status updates and adequate documentation within study management systems

• Preparing and submitting clinical education programs to both AARC and ARCF for clinical certification.

• Apply knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures.

• Apply relevant clinical research support experience to create project related documentation and maintenance. Ensures proper documentation within clinical study management systems and records management.

• Schedule and attend departmental meetings, along with preparing and documenting meeting minutes

• Manage HCP payments and product shipment documentation for annual (Sunshine Act) reporting

• Communicate with study sites to gather documents for clinical study status updates. Ensuring adequate documentation within study management systems.

• Liaised with study sites and principal investigators to track clinical study progress, ensuring all documentation is accurately maintained within study management systems. Coram CVS/Specialty Infusion Services Clinical Trials Consultant March 2017 – May 2020

• Coordinated clinical study data, ensuring it is tracked and standardized across all platforms.

• Participate in the development and revision of documents and study support materials (homecare training manuals, homecare visit forms, etc).

• Track progress of projects and identify appropriate actions to achieve target objectives.

• Serve as a point of contact for Sponsors and Investigator Sites participating in the study.

• Review documentation/source documents for completeness and accuracy.

• Review and verify invoices for study-related services.

• Maintain study files and trial tracking systems.

• Review and monitor regulatory binders and accountability logs

• Liaise with vendors, pharmacies, and HCAs.

• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.

• Assist with training, mentoring, and development of new Clinical Trial Associates and Administrative

• Assistants within Coram Clinical Trials (CCT), as the need arises.

• Understand and comply with Good Clinical Practice (GCP) and internal Policies and Procedures

(P&Ps).

• Respond (same business day) to all telephone/fax/e-mail correspondence from Investigative Sites and Sponsor and maintain documentation of all such correspondence or forward contacts to appropriate CCT person for response in a timely manner.

• Lead and orchestrate trainings for nurses and coordinators at clinical sites.

• Assisted with implementing a new filing system for a clinical trial.

• Inventory of patient files and request of documents.

• Quality checking source documents for completeness, accuracy and compliance with sponsor protocol and guidelines.

• Conduct proactive and periodic audits to ensure all clinical trial documents are filed appropriately and accordingly.

• Responsible for coordinating and managing contracted homecare services in the support of sponsored projects and Phase I – IV clinical studies in a variety of therapeutic areas. Cordant Health Solutions Sales Support/Customer Care Coordinator January 2016 – February 2017

• Managed client supply logistics, ensuring timely and accurate delivery.

• Create and update client account information up to HIPPA and GCP standards

• Create drug testing panels that are used for patients and clients

• Add and adjust pricing for clients and company

• Create proposals that are presented to clients in order to promote sales

• Communicate with clients over phone and email in order to help sales representatives

• Schedule deliveries and pick up for pharmaceuticals and toxicology equipment

• Discuss and resolve prior authorizations with insurance companies, medicaid, medicare and other pharmacies.

• Monitor patients prescriptions by calling doctor offices when refills are needed.

• Promote sales of opiod antagonist's such as Naloxone, Narcan, and Evzio. CSL Plasma Receptionist/ Donor Support Tech August 2015 – December 2015

• Screened patients prior to donating by documenting clinical information including vitals, blood plasma levels and prior medical background.

• Prepared medical equipment for patients while discussing necessary information to patient prior to use

• Demonstrated to patients how to use equipment, while answering question discretely and reliably

• Responsible for preparing the donor, donor area and equipment for the pheresis process

• Prepares the autopheresis machine for the pheresis process

• Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process

• Disconnects the donor when the process is complete

• Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff

• Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events

• Uses PDA to link equipment and soft goods used in the pheresis process to the appropriate donor

• Alerts Group Leader or Supervisor of donor flow issues

• Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the Standard Operating Procedures (SOPs)

• Understands the policies and procedures associated with hyper immune programs at the center if applicable

• Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed

• Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration

(OSHA) policies and procedures

• Promotes safety in all actions

• Maintains confidentiality of all personnel, donor and center information

• Cross-trained in other areas to meet the needs of the business Colorado State University Medical Clinic Student Assistant October 2012 – May 2013

• Effectively gathered vitals of patients prior to seeing physician

• Documented patients chief complaints with surgical and anatomical terms

• Noted patient history and personal information

• Assisted doctors with patient exams

• Prepared blood samples for lab tests

• Sterilized medical equipment

• Updated patient details in medical records

• Schedule patient appointments.

INTERNSHIPS/ APPRENTICESHIPS

Poudre Valley Hospital Pulmonary Rehabilitation Assistant Intern, 2015

• Monitored patient vitals, including blood pressure, ensuring accurate and consistent data collection.

• Assisted medical staff with the collection and documentation of medical data, contributing to patient care quality.

Colorado State University Cardio and Pulmonary Rehab Intern, 2015

• Engaged with clients, accurately documenting vitals and providing education on managing risk factors, including high blood pressure, diabetes, and high cholesterol.

• Supported clients in weight management and nutrition planning, promoting overall health and wellness.

References available upon request

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