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Project Manager Clinical Research

Location:
Longmont, Colorado, United States
Salary:
80,000
Posted:
December 31, 2018

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Resume:

EMPLOYMENT HISTORY

June **** to Present

Project Manager II

ERT, Longmont, CO/United States

●Gathering customer requirements and relaying to internal teams

●Developing study documentation

●Distributing/tracking equipment

●Creating/distributing reports

●Archiving study data and documentation

●Appropriately setting and fulfilling customer expectations

●Budget reviews

●Revenue forecasting

●Scope changes

●Invoice reconciliation

●Identify potential study risks and mitigations and escalate as appropriate.

●Manage internal/external negotiations and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations

●Apply problem solving strategies to address customer issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to customer escalations

●Serve as PM point of contact for operational readiness regarding new product initiatives

●Ensure compliance with timely training completion/documentation

●Present study services at Investigator Meetings or site initiation meetings as needed

●Attend client meetings with Business Development and/or Operational teams to present Company services and Operational Data flow, as needed and participate in sales initiatives to generate incremental revenue

●Assist with training new members of the Project Management team.

●Perform other duties, assignments, or special projects as time and/or circumstances necessitate.

November 2017

to June 2018

Project Manager

ERT, Longmont, CO/United States

●Gathering customer requirements and relaying to internal teams

●Developing study documentation

●Distributing/tracking equipment

●Creating/distributing reports

●Archiving study data and documentation

●Appropriately setting and fulfilling customer expectations

●Budget reviews

●Revenue forecasting

●Scope changes

●Invoice reconciliation

●Identify potential study risks and mitigations and escalate as appropriate.

●Apply problem solving strategies to address customer issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to customer escalations

●Ensure compliance with timely training completion/documentation

●Present study services at Investigator Meetings or site initiation meetings as needed

●Assist with training new members of the Project Management team.

●Perform other duties, assignments, or special projects as time and/or circumstances necessitate.

February 2016

to November 2017

Project Manager

iCardiac Technologies, Longmont, CO/United States

●Manage project from initiation to completion, including timeline adherence, internal and external communications, financial tracking, and project deliverables

●Assist in the generation of detailed Project Execution Plans based on study protocols and/or service agreements

●Serve as the primary project contact internally and externally, and interact with client/customer to assure comprehensive management of projects, while delivering high quality service

●Organize and lead inter-departmental activities to ensure completion of the project on schedule and to ensure that the internal project team members fulfill their project plan responsibilities in accordance with scope of work and project plan

●Ensure that all project deliverables are accurate, meet internal requirements, and are completed in accordance with client specifications and expectations

●Facilitate project changes and timeline adjustments and prepare associated documentation.

●Perform risk assessment and escalation to management

●Present and provide training at investigator meetings, kick-off meetings, and site initiation visits as required by the study

November 2014

to February 2016

Senior Clinical Research Coordinator

Aventiv Research, Columbus, OH/United States

●Independently developed and implemented plan to manage studies, i.e: patient recruitment, study conduct, Investigational Product management, patient safety, AE/SAE management, maintain patient engagement/retention, data entry, collection of biological samples, collection of ecg's

●Managed multiple study protocols

●Maintained required records of study activity including case report forms, drug dispensation records, or regulatory forms, and remote data capture

●Collaborated with principal investigators, Sub-investigators, sponsoring agencies, marketing agencies, and research team

●Oversight of Staff

November 2009

to November 2014

Clinical Research Coordinator

Aventiv Research, Columbus, OH/United States

●Organized, coordinated and documented care of patients

●Carried out protocol specific guidelines

●Identified, assessed eligibility and recruited patients

●Collected and distributed biological samples, collected ecg’s, and data input

●Collaborated with principal investigators, Sub-investigators, sponsoring agencies, marketing agencies, and research team under the supervision of clinic team

May 2008

to November 2009

Clinical Research Coordinator

The Ohio State University, Department of Psychiatry, Columbus, OH/United States

●Organized, coordinated and documented care of patients

●Carried out protocol specific guidelines

●Identified, assessed eligibility and recruited patients

●Collected and distributed biological samples, collected ecg’s, and data input

●Collaborated with principal investigators, Sub-investigators, sponsoring agencies, marketing agencies, and research team under the supervision of clinic team

May 2007 to May 2008

Research Assistant

The Ohio State University, Department of Psychiatry, Columbus, OH/United States

●Performed venipuncture, ECG’s laboratory testing, processing and shipping

●Assisted coordinators in various tasks including filing, recruitment, patient charting and data entry

●Attended to patient care/needs

November 2004

to May 2007

Psychiatric Care Technician

The Ohio State University, Columbus, OH/United States

●Lead technician for the geriatric program

●Served on a committee to ensure proper and efficient training for new technicians

●Organized and ran patient education groups, attended to patient needs/requests, and documented patient information according to specific hospital guidelines

EDUCATION

December 2003

Interpersonal Communications

Bachelor of Arts

The Ohio State University, Columbus, OH

MEMBERSHIPS

2010-2017

2009-2017

2007-2016

REFERENCES

ACRP

●Certified Clinical Research Coordinator

●ICH-GCP Certification

●IATA certification

Available upon request



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