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Monitoring Manager

Location:
Wake Forest, North Carolina, United States
Posted:
April 29, 2019

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Resume:

Lisa Estes Lutz

*** ********** ****** ****, **** Forest, NC 27587

919-***-****

https://linkedin.com/in/lisaestes

ac88qz@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Summary:

I have been in clinical research since 1999 starting as a Clinical Research Associate. I have experience with Contract Research organization as well as Pharmaceutical companies. Some of my experience includes CRO/monitoring oversight including vendor selection and budget/invoice review; Study start up activities; Track progress of study deliverables; Contribute to the finalization of clinical protocols/amendments, informed consent templates, study guides, eCRF, study plans, etc.

Pharmaceutical Product Development, Raleigh, North Carolina, USA November 2018 to present

Manager, Clinical Management (FSP CRA Line Manager for GlaxoSmithKline)

Oversees daily line management responsibilities of assigned team. Serves as a positive leadership and professional role model for respective CRA staff. Ensures overall site quality, regulatory and Good Clinical Practice compliance with Global clinical trials.

Manages staff, providing coaching, mentorship and work direction.

Conducts regular performance appraisals and career discussions with staff.

Manages and conducts orientation programs for all new employees, ensuring their smooth assimilation into the company.

Supposrts allocation activities perthe local resourcing process. Supports activities of GSK clinical team managers to optimize the operational running of projects.

First line of escalation of any project/ site issues to ensure deliverables are met.

Review of monitoring reports and metric dashboards to ensure compliance with Risk Based processes.

Allergan, Inc. Raleigh, North Carolina, USA, August 2011-March 2018

Senior Manager, Clinical Vendor Oversight, September 2016-March 2018

Ensure process for selecting vendors is completed appropriately, executed, and documented per Allergan’s procedural requirements. Assist Clinical Trial Team with the selection of all vendors for the clinical trial.

Review and provide input into request for proposals (RFP) and contracts with the functional or study team.

Develop relationships with vendors to enable mutal understanding of expectations deliverables and issue resolution. Work with operations and all line functions (as applicable) to resolve performance issues. Establish communication pathways with vendors, clinical development, and procurement to discuss performance and clinical trial issues.

Participate in vendor Governance meetings and formulate Governance strategy for the vendor.

Ensure vendor risk analysis, assessment and reassessment visits are conducted on-time and appropriately, including arranging visit, preparing Allergan staff to conduct visit, compliling final reports from all functional areas and submitting to Global Regulatory Compliance with audit request if required.

Prepare vendor oversight documentation for pre-audit preparation. Participate in audit/CAPA debrief meetings. Support the resolution of CAPA and audit responses related to vendor issues.

Establish and monitor vendor Key Performance Indicators (metrics review).

Experience with CRO, reading centers, laboratory, imaging centers, IVRS, data management, Phase I, transparency reporting and regulatory vendors.

Manager, Clinical Monitoring/CRO Oversight, October 2014 to September 2016

Participate in Clinical Trial Team meeting to ensure productive and successful clinical trial. Managed timelines for key delieverables, including assisting with developing protocols, case report forms, statistical analysis plans, data management plans, monitoring reports, training plans, recruitment plans, communication plans, monitoring oversight reports and clinical study reports.

Oversight study related site management and monitoring activities.

Responsible for management, training and development of CRAs.

Participate in CRO selection activites and management of CRO

Analyze, interpret and proactively identify and escalate site or study issues using available remote data dashboards, monitoring report review and metrics, as provided by the Preferred Provider(s) and/or Allergan internal systems.

Assist with site inspection readiness activities, including preparation for sponsor audits and regulatory inspections.

Review and approve 100% of Sites recommended for Selection into the trial.

Global responsibilities for NA, LA and APAC.

Lead CRA Ophthalmology, May 2012- Oct 2014

Provide oversight on monitoring activities associated with the site-level feasibility, evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trials sites in the therapeutic area assigned.

Act as the first line of contact between the study team and the field based monitors.

Conduct training of the monitoring plan, CRF completion and other monitoring tools as well as coordinate and/or conduct therapeutic training.

Assist with corrective and preventative action responses to monitoring related observations on audits and inspections and provide study specific audit lessons learned at monitor meetings/calls.

Responsible for appropriate CRA resourcing for assigned clinical trials.

Responsible for trip report review.

Line management responsibilities for Allergan, FSP and contract CRAs.

Global responsibilities for NA, LA and APAC.

Principal CRA Dermatology and Ophthalmology, August 2011- May 2012

Direct study and site management activities for studies across multiple therapeutic areas to ensure optimal performance; meets or exceeds metrics-driven objectives with regard to timelines and quality data, subject recruitment, and operations; foster collaborative relationships with cross-functional peers and site personnel to engage commitment to quality excellence and timeliness; ensure compliance with sponsor, local federal regulation and policy.

RPS on assignment with Allergan Raleigh, NC, USA, November 2009- August 2011

Senior CRA

Monitoring Phase I-IV trials. Conducting SQV, SIV, monitoring and close out visits. Lead CRA in dermatology. Mentor for new hires and territory development in North Carolina.

Kforce on assignment with Merck Raleigh, NC, USA April 2005- November 2009

Senior CRA

Monitoring Phase II-IV trials. Conducting SQV, SIV, monitoring and close out visits for Merck & Co. Mentor for new hires. Territory development for North Carolina.

EDUCATION

Bachelor of Science in Public Health, University of North Carolina at Chapel Hill, USA

QUALIFICATIONS AND SKILLS

Research Indications:

Cardiology

Oncology

Rare Diseases

Respiratory

Infectious Disease

Neurology

Ophthalmology- front and back of the eye

Urology

Vaccines

Women’s Health

Dermatology

Pain Management

Phase I-IV

Skills:

CTMS, BioClinica CTMS, Impact, eTrack

Inform, Medidata

PhlexGlobal, Firstdoc, eDX, GoBalto

Word, Excel, Powerpoint

Cross functional team experience

Global trial experience



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