Constance O’Sagie

SUMMARY:

Experienced Clinical Trial Manager with extensive research experience within various therapeutic areas including Dental, CNS, Rare Disease, and Oncology.

Experience in oral health drugs Combination treatment and Radiographic contrast agents. Sodium Iodide for Dental Plaque, Dental Caries, Dental Pain, and Dental Malocclusion in Phases I, II and III.

Experience in Infectious Disease Drugs for Infectious Disease for COVID-19 in Phase II.

Experience working with Cardiovascular Drugs for Cardiopulmonary Bypass, Congestive Heart Failure, and coronary heart disease in phases I, II, and III.

Experience in Metabolic and Dermatology drugs for Type 1 Diabetes, and Alopecia in phases I and II.

Experience in Oncology drugs for Breast Cancer, Triple Negative Breast Cancer, Prostate Cancer, Lung Cancer, Bladder Cancer, Cervical Cancer, and Advanced Solid Tumor (x3) in phases I, II, and III.

Strong leadership experience with managing clinical projects from study start-up through maintenance and closeout to meet study deliverables.

EDUCATION:

Bachelor of Science in Dental Surgery.

EXPERIENCE:

NEXUS Clinicals Weston, FL.

Clinical Trial Manager

Oct 2017- Mar 2022

Participate in routine reviews of the scope of work, budgets, vendor performance, and issue resolution.

Confirm that the eTMF is correctly set up and maintained appropriately throughout the trial.

Support the Feasibility process to ensure site selection is completed per the expected timeline.

Provide training as needed for study team members including monitors and any other activities that support site readiness to recruit, and inspection readiness

Manage and lead cross-functional study teams, including vendors

Act as the primary point of contact supporting the planning and execution of clinical trials

Manages study start-up and developed clinical study plans, Investigator site templates

Prepares and presents materials for Investigator meetings, bid defense, and CRA training

Reviews and approves investigator site payments, CRA expenses, and timesheets

Provide leadership and site relationship management to Clinical Trial Partner sites to support optimization of key processes and ensured critical trial milestones/timelines were met.

Review trip reports and manage CRAs to ensure quality and compliance per annotated trip report.

Developed the study milestones and accurate tracking of project timelines

NEXUS Clinicals Weston, FL.

Senior Clinical Research Associate

Aug 2014- Oct 2017

Participated in pre-study/initiation meetings with site investigators and study coordinators to ensure a complete understanding of the clinical study objectives and data requirements.

Ensured delivery of all supplies and equipment to assigned study sites

Coordinated activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.

Performed pre-study visits, reviewing study-related information with potential investigators (study synopsis, study logistics).

Clinical study report in compliance with ICH-GCP guidelines and as per SOP

Provided necessary study updates to Clinical Management regularly.

Data management plans ensuring adherence to GCP, HIPAA, and FDA/EMA guidelines

Performed study Interim Monitoring Visit and closeout visit activities ensuring that required documents are in order

Drafted visit reports within 5 business days to ensure timely report finalization

Established and maintained a working relationship with study coordinators and investigators at assigned study sites.

Ensured accuracy and completeness of the data in CRFs and resolution of data queries.

Reported trends and observations noted at sites to the study team.

Veristat CRO

Entry Level - Clinical Research Associate

June 2013 to Aug 2014

Conducted site-monitoring visits to assess the qualification of potential investigative sites, initiated studies, and instructed site personnel on the proper conduct of studies, reviewing data and ensuring the accuracy of data collected and closing out sites.

Conducted PSV, IVM, and COV visits on assigned projects

Provided regular clinical status information to team members and project management.

Ensured accuracy and completeness of the data in CRFs and resolution of data queries.

Participated in pre-study/initiation meetings with site investigators and study coordinators to ensure a complete understanding of the clinical study objectives and data requirements.

Ensured delivery of all supplies and equipment to assigned study sites

Coordinated activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.

Performed pre-study visits, reviewing study-related information with potential investigators (study synopsis, study logistics).

Performed study closeout visit activities ensuring that required documents are in order

Established and maintained a working relationship with study coordinators and investigators at assigned study sites.

Kohlmeier Lab Chapel Hill, NC

Research Assistant, Dental Study

Apr 2009-May 2013

Assisted with the development and execution of clinical research

Managed recruitment, screening, enrolling, and randomizing of oral and periodontal subjects into a clinical trial.

Assisted dental hygienist and dentist with dental care and treatment

Collected and processed biological samples and clinical data.

Assisted the principal investigators, clinicians, and trainees in the preparation for and execution of clinical research subjects.

Assisted with study coordination and execution.

Collaborated with sponsors.

Bailey Orthodontics Houston, TX

Orthodontic Dental Assistant

Mar 2007-Jan 2009

Performed orthodontic chair side assistance: adjustments, banding, bonding, fixed retainers.

Delivered patient oral hygiene and orthodontic care instructions and explained to patients details about every appointment

Scheduled patient appointments

Placed Invisalign attachments and buttons

Instrumented cleaning, sterilization/disinfection, and operatory disinfection

Poured and trimmed models

Scanned patients with an iTero scanner.

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