SUMMARY

• 9+ years of work experience in Clinical Data Management on various Clinical trials and all phases.
• 5+ years of experience as a Lead clinical data Mangerleading data management activities, including Contract Research Organization (CRO) oversite for multiple clinical studies within a clinical development program.
• Worked in various studies mainly in Oncology for solid tumors like fibro adenoma (Breast), sarcoma (Bone), Lymphoma (Lymphatic system) measuring with RECIST 1.1 Criteria.
• Worked in various therapeutic areas including Oncology, Cardiovascular (hypertension, dyslipidemia), Diabetes (antidiabetic and hypoglycemic agents) and Central Nervous System (Alzheimer’s, depression and Parkinson’s)
• Participated in the design and oversight of the database, to include database build and User Acceptance Testing
• Created and provided reports on the progress and status of the on - going study data management activities and deliverables, ensuring assigned projects are delivered on track with high quality and accuracy. Extensive knowledge in planning, analyzing, and accomplishing CDM objectives in a timely manner
• Excellent knowledge of creating database hierarchy and performing UAT, Strong and comprehensive knowledge in all DM activities from study startup, study conduct, and study lock.
• Hands on experience in Protocol Review, eCRF design, eCRF Completion Guidelines (CCG), and Edit Check Specification
• Developed Data transfer specification (DTS) for external vendors and maintained Data Management Plan throughout the study
• Expertise in data cleaning and query discrepancy process along with SAE reconciliation, Lab Reconciliation and Vendor data reconciliation
• Excellent knowledge of CDASH and CDISC standards and guidelines, ICH GCP, 21 CFR Part 11 regulations and guidelines, Oversighted CROs, PK/PD Vendors and other third-party vendors in support of timeliness and data related deliverables, Good knowledge in MedDRA and WHO Drug.
• Effective team player with strong organizational and communication skills and self-motivated individual with strong technical, analytical, and quick learning ability

PROFESSIONAL EXPERIENCE

Lead Clinical Data Manager

Confidential, Raritan, NJ

Responsibilities:

• Responsible for various clinical data management projects, Mentor, train and supervise junior associates/contract data managers as needed in clinical data management processes and procedures.
• Lead CRF design, review, and validation of clinical database, including management of CRO activities in this area as assigned if required, independently lead several complex trials.
• Ability to create data management plans and other data management documentation as needed
• Monitor, progress and conduct of respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions.
• Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects
• Proactively organize and manages ongoing data review throughout study conduct, including being responsible for the correction of errors and discrepancies management for the life of a project, identify and address issues that may impact the quality of the data, deliverables, or timelines
• Responsible for identification of data handling processes for non-CRF data, including lab data and image handling
• Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets
• Lead efforts coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed
• Independently lead new data management initiatives and contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with the project leader data standards to implement
• Responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner.
• Diligently participate in compliance program-related activities as denoted by the supervisor or Chief Compliance Officer. Connect - Develop strategic partnerships with key internal stakeholders to ensure projects remain on target to project timeline.

Senior Clinical Data Manager

Confidential, Rahway, NJ.

Responsibilities:

• Responsible for the data management activities supporting clinical studies from database start-up through database lock.
• Performed vendor oversight and Contract Research Organization (CRO) management.
• Developed and reviewed study setup documents like Data Management Plan (DMP), Data Base Specification, Data Validation Specification, and eCRF Completion Guideline.
• Reviewed Test Scripts and performed User Acceptance Testing (UAT).
• Reviewed and updated Annotated Case Report Forms as per SDTM standards and coordinated with Database Programmer for database design.
• Performed all the Protocol Deviations activities like raise the queries to CRA and update the Protocol Deviation status as per business needs.
• Performed all Cross Form Checking to ensure consistency of data as a part of Query Management process.
• Reviewed all the duplicate and overlap data and raised the Confirmatory Queries as needed.
• Generated various reports like Data Listing Report, Query Report, User Report, Page Status Report, and Audit Trail Report for manual review.
• As a part of Study Metrics management, generated Subject Status Metrics, eCRF and Query Tracking Report, Outstanding Query Metrics, Query Aging Report, Local Lab Ranges status, and SAE Reconciliation Status.
• Analysed all the primary and secondary endpoints data of solid tumour in Oncology studies.
• Performed Local Lab and Central Lab Reconciliation process.
• Reviewed Data Validation Module (DVM) for Manual check creations.
• Prepared the Manual Listing Specification and review the Listing Output for Reconciliation process.
• Reviewed Serious Adverse Events (SAE) reconciliation.
• Coordinated with coding groups to ensure MedDRA coding of Medical History terms, adverse events and WHO Drug Dictionaries for concomitant medications.
• Prepared Database Modification Request form for any Postproduction changes with respect to Electronic Edit Checks or Database Updates.
• Detailed knowledge of drug development process and data management experience in accordance with ICH guidelines and FDA regulations.

Clinical Data Manager

Confidential, Greater Seattle area

Responsibilities:

• Provided oversight and accountability for more than one low to moderate complexity trial or one high complexity trial for data management activities
• Experienced a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s)
• Services rendered were adhered to applicable SOPs, WIs, policies, local regulatory requirements, etc.
• With the trial customer, CRO and other functional partners: - Gathers content and integration requirements for eCRF and other data collection tools
• Established conventions and quality expectations for clinical data and expectations for dataset content and structure
• Set timelines and follow-up regularly to ensure delivery of all Data Management milestones
• Performed trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction
• Reviewed clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency
• Ensured compliance with regulatory guidelines and the documentation matrix and real-time inspection readiness of all Data Management deliverables for the trial; Participated in Regulatory Agency and internal audits as necessary
• Planned and tracked content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival.
• Ensured deliverables are on time.

Clinical Data associate

Confidential

Responsibilities:

• Skilled in Clinical Data Management using EDC systems like Phase Forward Inform and Oracle Clinical with Good Clinical Practice (GCP) knowledge.
• Review clinical trials data in accordance with Global Data Management Plans and applicable standardized data management processes (Standard Operating Procedures, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
• Run ancillary programs (e.g. special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.
• Apply quality control procedures and checks to ensure data quality standards (client and Confidential ) are achieved.
• Assist with the reconciliation of central laboratory and/or third-party vendor data (Electronic Case Report Form, Electronic Diary, specialty laboratory, etc.)
• Assist with the aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation.
• Worked as a part of the Study Startup team which is responsible for Project Initiation, Planning, Implementation, Control & Evaluation and Close-Out activities which includes initiation of trial capacity, trial setup activities, etc.
• Developed and reviewed complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems.
• Analyzed and solved lower-complexity problems