MADDY NEIM

220-***-****

advtj6@r.postjobfree.com

A detail-oriented Clinical Data Management professional with a track record for success in progressively responsible positions within clinical environments. A systematic leader focused on overall accuracy in data administration with years as a Clinical Data Manager across Phase I-III studies. A keen interest in providing core comprehensive data management expertise with data management team members to create efficient, quality products that fit the client’s needs. Solid experience analyzing and designing case report forms across multiple vendors and clinical pathways; assisting with study management activities from study development, and start-up to database lock. Well-rounded in point-of-care strategic solutions and risk-based monitoring within various indications and therapeutic areas

PROFESSIONAL EXPERIENCE

REGENERON Senior Clinical Data Manager Apr 2020 - Present

• Participated in data management study startup, maintenance, and database lock activities

• Worked with clinical and biostatistics personnel and CROs to design and develop study documents

• Worked with CROs to ensure that outsourced data management tasks remain on target according to projects' timelines and budgets

• Development of case report form (CRF)

• Development of database (DB) clinical trial data specifications, user requirements, edit rules/checks, query logic and data validations, data review listing specification

• Development of data management plan, coding guidelines, SAE reconciliation plan

• Coordination/reconciliation of electronic data transfers (external data provider to DM vendor, DM vendor to Sponsor, other data source to Sponsor) and Data transfer agreements

• Interacted with clinical counterparts for project data cleaning and resolution of issues

• Implemented and executed internal data review plan and assist in data review

• Planned and performed UAT of clinical database, including findings management and communication

• Participated in cross-functional discussions to define data handling and design standards

• Assisted with defining projects timelines and deliverables and worked closely with cross-functional teams to deliver on them

• Assisted with ensuring that functional deliverables are completed according to the highest quality, ethical and professional standards

• Prepared and oversaw routine progress/metrics and ad-hoc reports, as required

• Supported standard operating process creation and process improvement ICON Clinical Data Manager April 2018 - Feb 2020

• Lead for internal/client team meetings and communication

• Produced and reviewed metric reports for internal/external project team

• Ownership for project deliverables within DM scope of services including projections

• Identified roadblocks and provides solutions for completing project objectives in a timely manner

• Provides training of other DM staff on project specific processes

• Created the data review plan and the DM listings using ad hoc query tools

• Issued queries and reviewed query responses with the highest level of quality based in accordance with the data review plan/guidance document; including manual review (AE/CM comparison, Inclusion/Exclusion review, etc.), and reconciliation

(LAB, SAE, ECG, and other vendors).

• Drafts the CRF design, edit check specification and DM listings

• Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc.)

• Manages all database build and modifications (expectations for timelines, UAT, production release)

• Data Management Plan, CRF Completion guidelines, Data Entry guidelines, Edit specifications, Reconciliation guidelines, and Report specifications

• Database release documentation (blank CRFs, annotated CRFs, edit checks, configuration/workflow)

• Project Specific SOPs/WPs (as directed by PM)

ABBVIE Clinical Data Associate August 2016 - March 2018

• Conducted data reviews

• Responsible for the oversight of clinical data management study deliverables, evaluated and mitigated risks across programs.

• Provided technical oversight of service providers performing core data management functions including CRF/edit check development, UAT, data cleaning, listings review, and database lock procedures.

• Assessed the quality of the statistical programming processes through techniques including but not limited to good documentation code review and testing.

• Participated in cross-functional process initiatives.

• Provided input on the clinical data management system enhancements including performing UAT.

• Reviewed the development of database specifications, validation plans, and data management plans, ensuring alignment with the CRF, protocol, and safety data standards. THERAPEUTIC EXPERIENCE

• Central Nervous System: Alzheimer's disease, Parkinson’s disease, chronic pain, Migraine

• Oncology: Lung cancer, Cervical cancer, Breast cancer, pancreatic cancer

• Respiratory: COPD, ARDS, Emphysema, Pneumonia, Pulmonary edema

• Rare Disease: Pemphigus, Scleroderma, Von Willebrand disease, Systemic lupus erythematosus

• Medical Device: Heart valves, Stents, Inhalers

• Infectious diseases: Candidiasis, Diphtheria, Hepatitis A, HIV

• Vaccine: COVID 19, Influenza, RSV, Meningitis

• Cardiovascular: ACS, Hypertension, Heart failure SKILLS

• EDC: Medidata Rave, IBM, Inform, Oracle Clinca

• Dictionary coding MEDRA 23.1, WHODRUG Global B3.

• ICH/ GCP Guidelines

• Database Build, Edit Checks

• Vendor Reconciliation

• SDTM standards

EDUCATION

Bachelor of Biomedical Science

UNIVERSITY OF ABERDEEN (2011)

MASTER’S IN MEDICINE

GEORGETOWN AMERICAN UNIVERSITY (2022)

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