Nilka Yusely Malamut has over 15 years of experience in project management for clinical trials, most recently as a Senior Project Manager at Cardiocore in Rockville, MD. She has successfully managed over 30 clinical trials projects on time and under budget. Prior to her current role, she held positions in customer support, project management, and service department management for medical device companies. She has a Bachelor's degree in Industrial Engineering and is a certified Project Management Professional.

1. Nilka Yusely Malamut
Clarksburg, MD, 20871 (240) 281-5223 YUSEL12@yahoo.com
Summary
 Experienced Project Management professional with extensive knowledge in the Medical/Research Field.
 Strong organizational, communications, management skills, proficient at leading the team responsible for
achieving the project objectives.
 Skilled at learning new concepts quickly, working well under pressure, and communicating ideas clearly and
effectively.
 Enthusiastic and experienced in overseas travel.
Professional Experience
Cardiocore, Rockville, MD
Senior Project Manager January 2012 - Present
Responsible for the overall plan and management of multiple clinical trial projects, individually and/or within
specific customer programs, from phase I to phase IV, including rescue studies, focus on project’s timelines,
budgets, resources, study sites, and key project deliverables.
 Manage processes to ensure compliance with the study protocol, all pertinent regulations, Quality System
Procedures and ICH/GCP guidelines.
 Successfully completed over 30 projects as Senior Project Manager on all study phases, under sponsor’s
timelines and budget.
 Facilitate meetings with stakeholders to discuss project status, forecast and potential changes in budget,
provide risk analysis, allowing early visibility and resolution of issues and maintaining projects on schedule and
under budget.
 Mentor and coach junior team members and Associate Project Managers in Project Management activities for
all study phases.
 Run metric programs for key customers, provide quantified results on company’s deliverables, adjusting the
level of services and improving internal processes when goals are not above determined thresholds.
 Support the Business Development team with study proposals and bid defenses either in person or over the
phone.
 Develop change control procedures for unique project requirements.
 Report regularly project status and budgets to Senior Management for department forecast.
Project Manager January 2007 – January 2012
Responsible for initiating, planning, executing, monitoring and controlling, and closing assigned clinical trials
projects
 Perform site and study team training at Global Investigational Meeting for study related processes and manage
site’s expectations.
 Participate in sales presentations as a representative of the project management department
 Work with Quality Assurance to write or update SOPs and WIDs as needed
 Manage study timelines, budgets, resources, and key project deliverables, with weekly study reports to
sponsor’s team, with the overall goal of keeping project status information available and potential study issues
under control.
 Conduct regular project meetings with clients to provide updates, resolve issues and ensure high client
satisfaction.
 Track and report customized project status reports to clients

2. Senior Customer Support Specialist August 2006 – January 2007
Provided front-line support and training to worldwide internal and external customers via phone, fax and email.
 Responded to and resolved customer inquiries and request for technical information.
 Provided recommendations for service set-up, usage and troubleshooting.
 Troubleshot reported problems at Cardiocore, provided workarounds and recommendations, replicated and log
the incident in the tracking software
 Worked closely with on-site Clinical Operations and IT management as part of the Customer Support Team.
 Followed procedures described in the Standard Operating Procedures and adhered to the Service Level
Agreements.
 Prepared, configured and tested ECG equipment to be sent to sites.
 Provided after-hours Helpdesk coverage when necessary.
 Programed and tested ECG and Holter equipment and shipped it globally.
 Additional responsibilities included: processing equipment returns, managing inventory of equipment and
supplies and maintaining and updating inventory system.
 Performed other tasks as assigned by department manager.
Service Department Manager, Medispec LTD. Germantown, MD. July 2004 – August 2006
 Supervised a team of 4 people
 Provided technical support to customers, as well as served as liaise on service calls with customer and a third
party company’s service department personnel.
 Designated and coordinated equipment for sale, rental and demo. Oversaw equipment delivery and
coordinated shipping methods
 Scheduled equipment installation at Hospitals, Surgery Centers and Doctor’s office.
 Received and shipped orders for spare parts and consumables, from/to USA, Canada, and Israel.
 Ordered equipment and service contracts through third party vendor (GE OEC).
 Maintained and performed Preventive Maintenance Services on all equipment, new, sold and leased, keeping
clear and traceable records.
Additional responsibilities included: evaluating, developing, documenting and implementing cost savings for the
department in general.
Education
B.S. Industrial Engineering with Specialization in Management.
University of Tachira. Venezuela
Project Management Professional Certification (PMP#1679852)
Project Management Institute
Memberships & Affiliations
Project Management Professional Certification (PMP#1679852)
Project Management Institute
Special Skills
MS Office, MS Outlook, MS Power Point, MS Project.
Languages: Spanish and English