Data Analyst Clinical

SUMMARY

A highly experienced, IAOCR certified, Sr. Manager (Risk Based Monitoring) with considerable experience within the CRO/Pharmaceutical environment. Key experiences are within Cardiovascular, Endocrine, Genitourinary, Hepatic and Biliary Disorders, Infectious Disease, Musculoskeletal, Neurology, Oncology, Pediatrics, Psychiatry, Medical Device, Decentralized Trials and Phase I Management.

EXPERIENCE

Date: From June 2021 – March 2024

Company Name: Premier Research

Job Title: Sr. Manager, Clinical Data Sciences

Provides all aspects of line management supervision to Clinical Data Analyst staff including, but not limited to, performance management (quality, quantity and timeliness of work performed), and guidance on corporate policy, training and support

Assists in staffing activities such as recruiting, hiring, interviewing, proposal and budget development, monitoring resource assignments, and retention of high-quality monitoring staff

Works with the CMS leadership to implement effective orientation, mentoring, and career development programs for Clinical Data Analyst staff

Assists in reinforcing therapeutic and project-specific training as requested by project management

Assist Clinical Data Analyst in identifying study risks and analytics for Risk Based Monitoring

Perform data review, identify and mitigate/escalate issues, trends, and outliers for studies assigned.

Identify protocol deviations and enter in CTMS, and issues queries as needed for studies assigned

Provide remote EDC monitoring for DCT trial studies assigned

Subject Matter Expert for our proprietary system used for clinical data analysis of study Key Risk Indicators

Present at qualifying and study audits, to include follow up on findings if necessary

Assists with writing SOPs, WG, and study processes, training matrix, and new hire presentations

Submit forecasted hours for CDA role for all ongoing studies for study progression

Performs additional duties and assignments as requested

Date: From July 2019 to June 2021

Company Name: Premier Research

Job Title: Manager, Risk Based Monitoring

Provides all aspects of line management supervision to central monitoring staff, including, but not limited to, performance management (quality, quantity and timeliness of work performed), and guidance on corporate policy, training and support

Assists in staffing activities such as recruiting, hiring, interviewing, proposal and budget development, monitoring resource assignments, and retention of high-quality monitoring staff

Works with the CMS leadership to implement effective orientation, mentoring, and career development programs for Central Monitoring staff

Perform data review, identify and mitigate/escalate issues, trends, and outliers for studies assigned.

Identify protocol deviations and enter in CTMS, and issues queries as needed for studies assigned

Provide remote EDC monitoring for DCT trial studies assigned

Assist Clinical Data Analyst in identifying study risks and analytics for Risk Based Monitoring

Subject Matter Expert for our proprietary system used for clinical data analysis of study Key Risk Indicators

Manages individuals at remote locations and ensures they have proper equipment and setup to function effectively from a remote location

Submit forecasted hours for CDA role for all ongoing studies for study progression

Performs additional duties and assignments as requested

Date: From Mar 2018 to July 2019

Company Name: Premier Research

Job Title: Senior Central Monitor

Liaises with the Clinical Manager, Project Manager, Clinical Research Monitor, Data Manager and Medical Monitor to ensure the escalation of observations of key risk indicators

Provides specifics regarding trends and safety risks associated with the observations and provides recommendations for next steps and/or resolution

Verifies that reported data is reviewed and analyzed according to the Clinical Monitoring Plan, Project Management Plan, Standard Operating Procedures and Risk Mitigation Plan in place for their assigned projects.

Identifies the need for sites to be retrained on study procedures or EDC entry

Meets with appropriate Project Team members at the beginning of the study to ensure understanding of project scope and any applicable vendor reporting and documentation requirements that may be necessary during the data review process

Conducts Project Risk Review/Assessments

Reviews defined KRI for the assigned study and acts if a safety signal triggers necessary action

Reviews items that will not be picked up by the programmed edit checks by utilizing project specific visualizations to review data for outliers, inconsistency, and potentially incorrectly entered data

Mentor less experienced Central Monitors and new hires on an as needed basis

Performs additional duties and assignments as requested

Date: From Apr 2015 to Mar 2018

Company Name: Syneos Health (formerly INC Research)

Job Title: Central Monitoring Associate II/III

Responsible for remote monitoring and site management of Phase II - IV clinical research studies, conducting all types of remote monitoring visits, inclusive of monthly site management calls (SMCs), PSSV’s, IMV’s, and Close out visits

Effectively co-monitored on site with partnered CRA

Assured compliance with local regulations, Code of Federal Regulations (CFR)/International Conference of Harmonization (ICH) and GCP Guidelines, and Company and Sponsor SOPs

Critically evaluated adequacy of Investigator sites (qualifications, facilities, equipment and performance)

Planned and conducted study initiation calls for Investigator sites

Completed and submitted monitoring call reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work

Documented and tracked the resolution of all outstanding site-specific, protocol-related, quality or ICH/GCP compliance issues from contact to contact and anticipated/identified potential issues and implemented corrective actions

Remotely reviewed electronic data completed by sites and assisted the site in resolving queries and/or other identified data issues

Ensured eTMF was current and up to date including items such as telephone contact reports (TCRs), Essential Documents, etc.

Attended Investigator meetings, clinical monitoring staff meetings, project team meetings, and clinical training sessions

Monitored site performance metrics and patient enrollment and independently implemented the majority of action plans for sites not meeting expectations

Mentored less experienced CMAs and new hires

Assisted Clinical Team Lead with line management duties as needed

Date: From Jul 2012 to Apr 2015

Company Name: Syneos Health (formerly INC Research)

Job Title: Project Specialist II

Provided support to Project Manager to ensure contracted services and expectations of a clinical study were conducted

Supported Clinical Team Lead and clinical team to ensure study needs were met

Supported sponsor related tasks and projects

Maintained internal systems for assigned projects

Communicated with site personnel to obtain information necessary to determine site participation in a clinical trial

Attended meetings and other learning opportunities

Prepared and maintained documentation, plans, reports, schedules, databases, spreadsheets, logs, etc. to support functions

Compiled, prepared, and analyzed data and prepared reports. Provided administrative assistance for special projects as required by the Clinical Operations Management teams

Date: From Jul 2007 to Jul 2012

Company Name: PPD

Job Title: Clinical Team Leader

Managed a team of 10 - 12 people to conduct Phase I clinical trials for multiple sponsors in accordance to contract

Provided operational expertise for the successful cross-functional delivery of assigned global early development clinical trial(s)

Responsible for overall coordination and execution of study procedures on multiple clinic studies

Reviewed protocols to determine study specific needs in order to run study successfully

Worked with all necessary departments, to include Principle Investigator to plan study conduction and ensure study needs were met

Attended and/or led multiple meetings with sponsors, team and other departments to ensure study was run correctly

Assured adherence to good clinical practices and compliance with all study protocols

Created and distributed team schedules to ensure study procedures were covered and run correctly

Conducted all management duties such as interviewing and hiring, reviews and appraisals and disciplinary action as needed

Date: From Apr 2006 to Jul 2007

Company Name: PPD

Job Title: Sr. Clinical Coordinator

Reviewed assigned protocols to determine study specific needs

Coordinated all aspects of multiple ongoing clinical trials to include check in, study conduction and kinetics and check outs

Maintained effective communications with Investigators to review labs and study procedures, inclusion and exclusion criteria

Set up study logistics in order to run study successfully as per protocol

Attended study meetings as needed with sponsors, team members, and other departments

Assisted Clinical Team Leader with creating and distributing team schedules and ensured study assignments were carried out

Assured adherence to good clinical practices and compliance with all study protocols

Completed team procedures as scheduled and mentored new team members

Assisted Team Leader with line management duties as needed

EDUCATION

Year: 1989

Associates Degree, Medical Administration, Mansfield Business College, Austin, Texas

LANGUAGES SPOKEN (Please indicate skill level – basic/intermediate/fluent)

Native language: English

Other languages: Spanish (Basic)

EXPERIENCED IN:

Word

Excel

PowerPoint

Medidata Rave

Calyx

Data Labs

Clue Points

Spotfire

PROFESSIONAL AFFILIATIONS

Accredited Central Monitor, IAOCR, 2017

PHUSE – Risk Based Monitoring Working Group

PUBLICATIONS

White Paper – Centralized Monitoring: Exploring the Considerations and Challenges of Implementation

https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Risk+Based+Monitoring/WP-073.pdf

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