DEBORAH B. MECK
Summary
Dedicated, experienced, and passionate Clinical Trial Associate with expertise in phases I-IV clinical trials of diverse therapeutic areas. Technical and administrative activities range from trial feasibility and study start-up to study maintenance and closeout. Ability to negotiate Informed Consents (and Assents) while working directly with sponsors, vendors, investigational sites, Institutional Review Boards (central and local), and Clinical Research Associates (CRAs). Additional experience reviewing essential documents, study start-up, performing quality control audits of Trial Master Files (TMFs), study team training, and maintaining study trackers and CTMS systems. As a Central Monitoring Associate on oncology studies and a complicated vaccine study, I acted as a team lead by mentoring and training new team members, delegating assignments, and developing newsletters. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Courteous candidate with evidence of experience providing quality patient care and administrative services. Proven track record of success in streamlining operations, developing protocols and improving patient outcomes. Strong commitment to exemplary customer service and maximizing patient safety and satisfaction.
Overview
15
15
years of professional experience
Work History
Clinical Support Specialist
Precision for Medicine
- II (CSS) provides study and operational support to project teams throughout the project life cycle; may move into increased responsibilities as knowledge base and skills expand
- Oversight of CSS tasks to be provided by the Principal CSS, CTM, or delegated by the PM, as appropriate
- Adheres to ICH GCP and FDA guidelines
- Serves as a member of the Project Team and provides study and operational support with the goal to contribute towards efficient management of studies
- Fulfills the role of Lead CSS, as applicable
- Provides study support to the project team for study related activities (e.g., maintenance of study mailbox, blast emails/mail merges, study document formatting, binders, meeting minutes etc.)
- Conducts the development and revision of applicable CSS task-related study plans such as Site Activation Plan, TMF Plan, Translation Plan, etc., Oversees quality control of the documents/files as per study milestones outlined in the project plan, as applicable to localand regional standards
- Assists in the set-up maintenance, and final reconciliation of Trial Master Files according to the project plan
- Maintains quality control of the documents/files as per study milestones outlined in the project plan
- Collaborates with the project team and other internal functions to ensure that the TMF is audit/inspection ready
- Assists in planning, organizing, and executing project-specific meetings including but not limited to client meetings, CRA training, Investigator Meeting and PI meetings
- Assists set up and activities for study tracking for internal and/or external purposes (e.g., Study Team Training, Start-up Activity, TMF QC, etc.), as applicable
- Assists with study start-up of clinical studies under the direction of a more senior CSS or the CTM, may assist sites through the start-up process for feasibility and investigator recruitment, essential document collection, IRB/Ethics submission and IP Activation, as applicable to local and regional standards
- May conduct country or site level ICF review, as applicable to local and regional standards
- May conduct the translation process of site level documents, as applicable
- Point of contact for project-related requests for team members, Sponsors, and third-party vendors, as applicable
- Responsible for review, tracking and filing of the essential documents for investigational sites as well as follows-up on missing/incomplete/invalid documents
- Distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance
- Coordinate the distribution and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable
- May contribute to financial tasks for the study (e.g., investigator/institution/vendors payments), coordinating tracking,as applicable
- May coordinate eTMF progress with partnering CROs, with SME guidance
- May present applicable status updates during internal/external meetings (e.g., eTMF metrics, process reminders, etc.)
- May assist team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment)
- Supports onboarding or mentoring activities of CSS team members
- Performs other duties as assigned.
CLINICAL SUPPORT SPECIALIST II
03.2021 - Current
SENIOR PROJECT SPECIALIST
Syneos Health
12.2019 - 04.2020
- Remote Office)
- Set up, maintained, and closed out project files and study information (e.g., KPIs, essential regulatory documents, Trial Master File (TMF / Veeva Vault), enrollment, Adverse Events (AEs) and Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board (IRB) approvals, and data queries) on a variety of databases and systems
- Assisted with the investigator site-selection process and feasibility and conducted due diligence to ensure investigators have not been disbarred during study start-up and maintenance
- Led internal and external meetings and prepared meeting minutes and action items for meetings; followed up with team members on actionitems for closure
- Provided support for quality assurance activities and prepared documentation, and followed through to resolution of issues
SR. CENTRAL MONITORING ASSOCIATE, CLINICAL OPERATIONS
Syneos Health
02.2015 - 12.2019
- (Remote Office)
- Conducted remote data review within various systems (EDC, IVRS, CTMS, etc.) to ensure subject safety, protocol compliance, and eCRF review was conducted within 15 days of data entry
- Utilized critical thinking skills to interpret and identify data issues, adverse events, protocol deviations, and other unanticipated potential patient safety issues and/or major risks to data integrity and escalated appropriately
- Generated data eCRF queries as needed
- Communicated and liaised effectively between Clinical Operations Leads (COLs), Clinical Research Associates (CRAs), Project Team members, and, if appropriate, site staff
- Performed remote site qualification, site initiation, interim sitemonitoring calls, and close-out visits to ensure regulatory, ICH/GCP,and protocol compliance
- Immediately communicated/escalated serious issues to the project team
- Maintained a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operation Procedures (SOPs) and processes
- Assessed the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
- Applied query resolution techniques remotely and provides guidanceto site staff as necessary, driving query resolution to closure withinagreed timelines
- Identified trends within and across sites
- Supported subject/patient recruitment, retention, and awareness strategies
- Acted as primary liaison with project site personnel in collaboration with the on-site CRA
- Ensured all assigned sites and project-specific team members were trained and compliant with applicable requirements
- Provided training/mentorship to more junior-level Central
PHARMACEUTICAL DEVELOPMENT ASSOCIATE
Monitoring Associates, Endo Pharmaceuticals
09.2014 - 02.2015
- Worked with Clinical Operations to forecast drug product requirements and timelines as the primary study team representative for pediatric studies
- Managed site supply needs
- Worked with Pharmaceutical Development to assess product dating,storage conditions, primary components, analytical testing needs,and retain quantities
CLINICAL TRIAL ASSOCIATE AND STUDY
Endo Pharmaceuticals
07.2011 - 11.2012
- Supported Clinical Trial Team(s) while adhering to SOPs and
- ICH/GCP Guidelines
- Partnered with Quality Control personnel while conducting in-process Trial Master File reviews to ensure SOP and ICH/GCP compliance
- Collaborated with management in the development of study start-up and document management processes
- Assisted in the Investigator Site Selection process and feasibility
- Assisted investigator sites with Central and Local Institutional Review Board (IRB) submissions
- Submitted study documentation to Central Institutional Review Boards from study start-up through closeout
- Supported and advised investigator sites throughout the lifecycleof a clinical trial
- Registered and updated study information on ClinicalTrials.Gov
- Prepared documents for long-term storage upon study completion
- Assisted in releasing Investigational Product(s) to approved
- Investigator Sites
- Liaised with Associate Directors, Clinical Trial Managers, CRAs, Medical Monitors, and other departments to ensure quality, overall site management
- Assisted in the development of Sponsor Oversight Plans
CLINICAL TRIAL ASSOCIATE AND STUDY
ReSearch Pharmaceutical Services, RPS
12.2009 - 07.2011
- START-UP SPECIALIST, Supported Clinical Trial Team while adhering to SOPs and
- ICH / GCP Guidelines
- Reviewed and negotiated Informed Consent Forms and Confidentiality Agreements with Investigational sites
- Collected and reviewed regulatory documents (1572s, Financial Disclosure Forms, CVs, Medical Licenses, etc.) for accuracy and completeness from study start-up through close-out
- Partnered with the management team to assist with interviewing, hiring, and onboarding of Clinical Trial Associates
TECHNICAL ASSISTANT
08.2008 - 12.2009
- Supported Clinical Trial Team while adhering to SOPs and
- ICH / GCP Guidelines
- Constructed and maintained Trial Master Files
- Collected, reviewed, and maintained essential regulatory documents throughout the lifecycle of a clinical trial (Feasibility through Close-out)
- Acted as Team Lead (in Trial Manager's absence) and Host of Sponsor Audit with QA Manager
Education
Bachelor of Science - Global Communication Studies
New York University
New York, NY2006
Skills
- Project/Therapeutic Experience
- Regions:
- North America
- Indications:
- Oncology: Advanced and Metastatic Cancers, Renal Cell Carcinoma, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Melanoma, Cervical Cancer, Bladder Cancer, Gastric Cancer, Anal Cancer, Platinum-Resistant / Refractory Ovarian Cancer, Breast Cancer, Solid Tumors, Small-Cell Lung Cancer, and CD123-Positive Acute Myeloid Leukemia and Blastic Plasmacytoid Dendritic Cell Neoplasm
- Psychiatric: Generalized Anxiety Disorder
- Infectious Disease: Human Immunodeficiency Virus (HIV) and
- Staphylococcus Aureus
- Vaccine: Staphylococcus Aureus /4-Antigen Vaccine
- Pain: Interventional Pain Management; oncology, pediatric pain, post-herpetic neuralgia, and post-traumatic neuralgia
- Cardiology: Electrophysiology Device for paroxysmal atrial fibrillation (device)
- Nephrology: Chronic Kidney Disease
- Neurology: Epilepsy
- Rheumatology: Osteoarthritis and Juvenile Idiopathic Arthritis (JIA)
- Software Experience
- Clinical Research:
- Clinical Trial Management System: Medidata
- ETMF Systems:
- VeevaVault, SureClinical, Trial Interactive, and various proprietary Trial Master File
- Systems (TMF)
- Other:
- MS Office 365 (Word, Excel, Outlook, Teams, PowerPoint, Publisher, and SharePoint), Egnyte, Adobe Acrobat
- Adobe Photoshop, and DocuSign
- Deborah B Meck Curriculum Vitae
- 3
- Quality Improvement
- Support Services
- Progress Tracking
Timeline
CLINICAL SUPPORT SPECIALIST II
03.2021 - Current
SENIOR PROJECT SPECIALIST
Syneos Health
12.2019 - 04.2020
SR. CENTRAL MONITORING ASSOCIATE, CLINICAL OPERATIONS
Syneos Health
02.2015 - 12.2019
PHARMACEUTICAL DEVELOPMENT ASSOCIATE
Monitoring Associates, Endo Pharmaceuticals
09.2014 - 02.2015
CLINICAL TRIAL ASSOCIATE AND STUDY
Endo Pharmaceuticals
07.2011 - 11.2012
CLINICAL TRIAL ASSOCIATE AND STUDY
ReSearch Pharmaceutical Services, RPS
12.2009 - 07.2011
TECHNICAL ASSISTANT
08.2008 - 12.2009
Clinical Support Specialist
Precision for Medicine
Bachelor of Science - Global Communication Studies
New York University