Data Entry Clinical Trials

PROFESSIONAL SUMMARY

RELEVANT WORK EXPERIENCE

Highly skilled associate with 8+ years of experience in the pharmaceutical industry, specializing in the management and maintenance of electronic Trial Master Files. Proven ability to ensure eTMF completeness, quality, and compliance with GCP and regulatory standards. Adept at optimizing eTMF workflows and supporting audit readiness for multiple clinical trials.

AbbVie

Clinical Documentation Associate Oct/2019 to present

Remote, Charlotte, NC

Managing projects for overseeing the eTMF as a SME for at least 10 clinical trials, ensuring inspection readiness and ALCOA standards are met with all functional areas throughout.

Key performance indicators (KPIs) included measures of completeness, quality, and timeliness

Collaborate with study team members regularly to ensure accuracy, quality, and completeness within the eTMF using various tracking metrics (e.g. Spotfire, excel sheets, and CTMS data entry).

Supported the clinical operations teams, primarily in tracking, monitoring, organizing, and filing essential documents from study start until final eTMF archival.

Member of the clinical management team responsible for delivering Phase I-IV studies across multiple therapeutic areas according to SOPs and GCP/ICH guidelines.

Beyond assigned role, supported Clinical Team members and management in projects handling data queries, drug inventories, study invoice payments, enrollment tracking, medical writing inquiries, and document reconciliation with investigator site files.

Worked on projects with management on all studies' reporting and control of all members of clinical Study team starting with initiations until closeout.

Worked closely with the clinical documentation center and artifact owners to ensure inspection readiness, identify gaps, and implement corrective processes in.

Provided guidance and information to each study team member about the document’s relevance, status, and what is required throughout life of the study from initiation, maintenance (conduct) and through archival.

Conducted meetings informing team members about the study status, eTMF status, and retrieved missing document if necessary.

Mentored many junior staff with their onboarding through eTMF project delivery.

Hematogenix Laboratory Services

Clinical Study Coordinator Oct/2017 to May/2019

Tinley Park, IL

Deliver laboratory processing for up to 11 assigned oncology clinical trials

Support project managers in day-to-day global operations and workflow for multiple pharmaceutical clients, in financial and budgeting reconciliations.

Worked along with management leading CRAs and other members of the study from initiations until closeout.

Assumed data entry responsibilities for multiple studies, tracking and analyzing payments for study specific procedures and site expenses.

Utilize knowledge of clinical documentation business procedures, governed by GCP and ICH guidelines.

Communicate status of received specimen with sponsors and pathologist, answering queries on current and previously assigned studies.

Al Zalam Medical Ctr

Management Intern Sept/2017 – Dec/2017

Bridgeview, IL

Pediatric & Obstetric clinic seeing approximately 5,000 patients annually.

Managed all billing and scheduling for 7 staff members.

Designed a manual for entering patients into Cardio system targeted for billing purposes.

St Michaels Hospital

Vascular Technologist, (per diem) Apr/2006-Dec/2010

Newark, NJ

Independently conducted multiple case studies daily, including extra cranial cerebrovascular duplex studies, peripheral upper & lower extremity venous and arterial studies.

Conducted upper and lower segmental arterial pressure/ PVR.

St. Barnabas Medical Center

Vascular Technologist Jan/2006- May/2006

Lyon, NJ

Independently conducted 15-20 studies per day.

Performed all vascular screening recommending to doctors the condition of venous and arterial status of patients.

Bayer

Research Lab Tech Feb/2003-July/2003

Fairfield, NJ

Research testing patients for the percentage of erythrocyte after centrifuge of human plasmid.

Measured and recorded percentage of erythrocyte for Bayer clinical trial related to the One Touch Glucometer testing.

EDUCATION

SKILLS

DAVENPORT UNIVERSITY, GRAND RAPID, MI

Master of Business Administration (MBA), Healthcare Management & Certificate of Strategic Management April/18

UNIVERSITY OF MEDICAL AND DENTISTRY OF NJ (SHRP), NEWARK, NJ

Bachelor of Science, Vascular Technology Jan./06

Training received at the following: University of Medicine & Dentistry of New Jersey, St. Michael's Medical Center, and St. Clair Hospital.

RUTGERS UNIVERSITY/NJIT, NEWARK, NJ

Bachelor of Science, Biology May/2000

PASSAIC COUNTY COMMUNITY COLLEGE, PATERSON, NJ

Associate's degree, Liberal Arts of Natural Sciences Aug./1996

Proficient in working with Veeva Vault (eTMF class expert), CTMS SME, and other pharmaceutical spreadsheets.

Microsoft Office application

Vascular Sonography Duplex Ultrasound

Vascular Arteriograms

Fluent in English and Arabic

Coursework: Strategic Management, Project Management, Sustainability business management, Managing Operations across the Supply Chain, Medical facility manager internship.

Graduate Certificate in Strategic Management.

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