Samiha Doar
Dallas,TX
Summary
I’m a highly organized and highly productive global Clinical Program Manager, with experience across multiple therapeutic areas including nephrology, rare diseases, diabetic peripheral naturopathic pain, and more. My core expertise spans most of clinical operations, including study oversight, vendor scoping/ contracting/ management/ oversight/ protocol development/ departmental SOP creation/ site management/ study start up/ regulatory interactions/ GCP compliance/ patient recruitment/ investigator relations/ team management/ budget development/ management. I have technical expertise in clinical systems including Medidata (EDC and RTSM), Veeva (Vault for TMF, SSU, and CTMS). I’ve recently played an active role in multiple FDA/BIMO/EMA clinical investigator and sponsor inspections, several of which were in support of a recently FDA-approved novel product for a rare neurological disease. I’m interested in using my experience to join a high integrity organization to do hard things together, to celebrate successes together, and to continue my own learning and development.
Overview
11
11
years of professional experience
Work History
Senior Clinical Study Manager – Inspection Readiness & TMF
Scholar Rock
10.2023 - 04.2024
- Implement and maintain TMF quality control processes that are aligned to internal standards, regulatory requirements, and GCP
- Ensure TMF project documentation is maintained to the highest level of quality, accuracy, completeness, and compliance with regulations
- Lead and/or support TMF creation and/or TMF system implementation and configuration including the development of TMF management plan(s)
- Lead and/or support TMF maintenance, closure, transfer, migration, and integration activities per company and/ or CRO SOPs and standards
- Ensure accuracy, completeness, and quality of TMF content by driving, overseeing, and facilitating regular reviews and audits
- Ensure all documentation activities are conducted in compliance with GCP, relevant SOPs, and regulatory requirements and meet appropriate quality standards
- Drive and lead the development of metrics to assess the completeness and quality of the TMF and effectively communicate status updates to the study team and department management
- Work with external partners and study team to address gaps, issues and mitigate risks
- Build collaborative relationships with CROs; drive the timely filing of documents throughout the study cycle; provide process and/or tactical support for TMF-related remediation as needed
- Collaborate with and support the study team in defining and maintaining expected study documents throughout the study cycle, including ensuring appropriate maintenance of expected documents in the TMF
- Serve as the SME for TMF during inspections and audits; collaborate with teams and regulatory authorities on TMF-related inquiries and inspections
- Develop and implement TMF training processes and provide guidance to the study team and cross-functional stakeholders on TMF expectations, tools, procedures and compliance requirements
- Monitor and identify trends, communicate issues, and recommend policy and procedural changes to improve operations to the federal client prior to implementation
- Establish quality assurance standards and metrics for TMF policies and procedures working across the organization for the execution of TMF Operations processes and strategy
- Support CAPA Leads in the development of actions and follow-up on assigned actions in the TMF area.
Senior Clinical Study Manager
Reata Pharmaceuticals
06.2022 - 10.2023
- Evaluate and oversee the activities required to execute, conduct and complete global studies, managing to established timelines and corporate budgets
- Evaluate, select and manage clinical operation vendors to ensure adherence to scope of work, budget and study deliverables
- Evaluate, select and manage investigational sites to ensure adherence to scope of work, budget and study deliverables
- Function as Subject Matter Expert and primary liaison for site personnel and internal Reata personnel in regards to study related topics and/or questions
- Negotiate site study budgets and contracts
- Leads or participates on the cross functional clinical trial team (e.g., pre-clinical, manufacturing, data management, safety surveillance, regulatory, biostatistics, and quality assurance)
- Contributes to the preparation of clinical program documents (study proposals, study protocols, Clinical Study Reports and submissions)
- Develop, implement and ensure adherence to the monitoring plan for assigned studies
- Organize Investigator Meetings and any other internal/external meetings related to Clinical Trials and delivers presentations at these meetings
- Ensure the collection, accuracy and storage of study related documents
- Oversee study monitoring activities for assigned studies and personally conducts site visits as needed
- Conduct regular team meetings, assigning action items and due dates, as applicable
- Ensure the review and tracking of monitoring reports for content, quality, adherence to GCP and timely submission
- Identify obstacles and related solutions and implement plans, after management approval, in collaboration with the study team to ensure the study objectives, scope and timelines are being met
- Develop Corrective and Preventative Action (CAPA) plans for issues of non-compliance
- Track, measure and report the status of project milestones
- Assist in the development and implementation of clinical Standard Operating Procedures and associated tools
- Ensure appropriate escalation of issues to Clinical Operations Management.
Clinical Research Associate I & II
Medpace Inc.
11.2015 - 09.2017
- Provide monitoring and auditing oversight of clinical research trials on behalf of the sponsoring biopharmaceutical company in academic medical centers within the United States
- Perform verification of source documentation at each visit through review of patient charts and clinical research data to ensure compliance with the study protocol, standard operating guidelines, and federal regulatory agencies, as well as ICH/GCP guidelines
- Perform initial qualification visits to evaluate the capacity of the site to successfully manage and conduct the study
- Perform study initiation visits, reviewing with the site personnel the study protocol, regulatory issues, study procedures, and providing training on completion of study related documents
- Perform both on-site and remote monitoring visits
- Present at Investigator Meetings the expectations and requirements for studies
- Therapeutic experience includes: adult and pediatric oncology, diabetes, medical devices, and heart disease.
Biology Teacher
Mansfield Independent School District
01.2015 - 11.2015
- Full time long term biology substitute teaching the following science to 10th, 11th, and 12th grade: Geology, Anatomy, Life Science, and AP Environmental Science
- Worked with the school administration to set up an after-school study program to ensure the success of struggling students.
Microbiology Teaching Assistant
University of Texas at Arlington
05.2014 - 05.2015
- Worked solely to set up lab equipment, prepare chemical solutions, and assess inventory.
Chemistry and Biology Student Tutor
University of Texas at Arlington
05.2013 - 08.2014
- Aided students with the completion of assignments and lab reports
- Acted as a resource for students needing guidance in the following academic areas: General Chemistry I & II, Organic Chemistry, Biology I & II, Geology, Immunology, and Microbiology.
Education
Bachelor of Science in Biology -
University of Texas at Arlington
Skills
Autoimmune/Inflammatory MS, Crohn’s Disease, GVHD, Psoriasis, CTD-PAH, Raynaud’s, RA
Cardiovascular PAH, PH-ILD
Dermatology Radiation Dermatitis
Endocrine DM, T2DCKD, other CKDs, rare CKDs
Gastrointestinal Crohn’s Disease, GI Toxicity of Aspirin & NSAIDS (IIS), ZES
Infectious Disease Hospital Acquired Pneumonia, C-Difficile
Mental Health Addiction/Substance Abuse
Nephrology IgAN, ADPKD, FSGS, T1D CKD
Oncology Metastatic Melanoma, NSCLC, Radiation Dermatitis
Ophthalmology Ocular Inflammation & Pain, CEC Loss Following Cataract Surgery
Timeline
Senior Clinical Study Manager – Inspection Readiness & TMF
Scholar Rock
10.2023 - 04.2024
Senior Clinical Study Manager
Reata Pharmaceuticals
06.2022 - 10.2023
Clinical Research Associate I & II
Medpace Inc.
11.2015 - 09.2017
Biology Teacher
Mansfield Independent School District
01.2015 - 11.2015
Microbiology Teaching Assistant
University of Texas at Arlington
05.2014 - 05.2015
Chemistry and Biology Student Tutor
University of Texas at Arlington
05.2013 - 08.2014
Bachelor of Science in Biology -
University of Texas at Arlington
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