Sr. Clinical Data Manager resume example with 8+ years of experience
Goal-oriented professional with 8+ years of experience as a Clinical Data Manager adept at managing databases with strong leadership and relationship-building skills. Highly skilled in reasoning and problem solving and can work as an individual and as a part of a team. An ingenious, positive approach to work, with the ability to bring quick, innovative resolution to challenges. Outstanding ability to plan, analyze and accomplish the CDM objective in a timely manner. Strong and comprehensive CDM skills spanning from study startup, study conduct, and closeout activities. Proficient in e-CRF design specification, Edit check creation, data cleaning, and query process, SAE reconciliation, and lab data reconciliation. Efficient experience in managing CRO’s work, study start-up, study conduct, and study close- out activities of clinical trials to deliver clean and quality data. Excellent experience in the study setup and smooth study conduct, close-out, reviewing the performance, protocol deviation, and maintaining awareness of issues raised. Developed Case Report Forms (CRFs), Data management plans (DMPs), and User Acceptance testing (UAT) for multiple clinical projects in accordance with protocol specifications. Worked on study conduct activities like Data Validation, Discrepancy management, SAE reconciliation, and Lab reconciliation. Expertise in CRF tracking, database QC and database audit. Therapeutic experience in cardiovascular disease, respiratory disease, and Oncology Expertise in working with vendor management, team management, and client interaction and communicating with various other departments within the clinical research domain.
|
|
- Participated in the review of clinical protocols and amendments to coordinate the design and testing of data capture systems
- Participated as data management representative at study meetings
- Developed and maintained project documents like DMP, Data validation documents, CRF completion guidelines, and Data transfer agreements
- Created annotate CRFs based on the protocol specification
- Knowledge of clinical study setup process and randomizations
- Ensured launch, delivery, and completion of all Data Management Activities according to the contractual agreement and relevant Stand Operating Procedures (SOPs)
- Performed clinical trial data management activities for phases (1 to 4)
- Involved in the training of the internal team, CRA, CRO, and vendors based on the project requirements
- Participated in study setup, validation, and implementation of clinical databases
- Involved in creating Edit check specifications and performing UAT on different Medidata rave bases
- Reviewed clinical trial and Medidata rave data to ensure data integrity, consistency, and accuracy throughout the study
- Performed and reviewed reports for SAE, Lab reconciliation
- Reviewed query status reports and coordinated with different departments for unresolved queries
- Responsible for the day-to-day maintenance of the application systems in operation, including tasks related to identifying and troubleshooting application issues
- Performed QC of data for several trails
- Authored data management documents- Data management plan, CCG, DTA
- Accomplished quality control measures which are mandatory for the freezing and locking of the database.
- Responsible for maintaining the global library and implementation of CDISC/SDTM/ CDASH standards to study objects
- Reviewed creation and maintenance of all essential data management documentation including CRF specifications, eCRF, annotated CRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Transfer specifications, and Data Review Guidelines, in accordance with the protocol
- Assisted in study setup, validation, and implementation of clinical databases
- Reviewed query status reports and coordinated with different departments for unresolved queries
- Reviewed electronically processed medical records received from sites, external third-party datasets, and other healthcare-related data
- Responsible for timely initiation and completion of data management activities for ongoing studies
- Liaise with Biostatisticians regarding data validation and lock of the database, including management of discrepancies
- Attend and participate in teleconferences and face-to-face meetings with sponsor companies as the lead representative from data management
- Conducted quality control of data for several clinical trials
- Reviewed and developed data management plans for EDC and paper-based trails
- Communicated with monitor, database programming, medical coding, and statistical programming teams to ensure smooth functioning of studies
- Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members.
- Served as a primary point of contact for sponsors, vendors, clinical operations team, database programmers, medical monitors, and SAS programmers for the execution of CDM deliverables
- Support the study setup, conduct, and closeout (database lock) as per quality timelines
- Developed specifications, and documentation in line with SOP requirements
- Performed UAT testing to validate the database by using the test scripts
- Performed, and reviewed SAE reconciliation, and lab reconciliation
- Involved in preparing all major study documents for all the phases of the study
- Ensure documentation of study documents until archival as per customer expectation
- Meetings with the internal study team to understand study-related issues, workload distribution
- Assist DML and PL with study budgeting and resourcing
- Mentoring,
- Timely Metrics capture and reporting
- Coordinates work of other Clinical Data Management staff assigned to the project
- Tracked study progress and insisted associates and coordinator for data precision
- Accomplished quality control measures which are mandatory for the freezing and locking of the database.
- Responsible for ensuring data management documents are inspection ready
- Assisted in the design and development of clinical trial documents such as case report forms, field edit descriptions, and data validation plans
- Provided a clean, locked, quality database on time and within budget
- Handling and resolving discrepancies in the database
- Third Party Data reconciliation (Central Labs and PK-PD)
- Running client-specific tools to process all external data, performing data loads, deliveries
- Perform external checks to handle manual discrepancies and action the same
- Review the resolved discrepancies and close where appropriate
- Providing data listings in the required format as documented
- To ensure error-free, accurate, and quality data with no open queries
- Attend relevant study teleconference with the client staff
- Co-ordinate with the study manager with respect to any unresolved queries & close the same
- Prepared case report forms according to data entry guidelines
- Maintained timeframe logic statements and ensured accuracy in databases
- Identify data conflicts and issues on projects
- Supported clinical trials for Contract Research Organizations by providing accurate data.
By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy
Your data is safe with us
Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.
Resume Overview
School Attended
- Western Illinois University
- Dr. NTR University of Health Sciences
Job Titles Held:
- Sr. Clinical Data Manager
- Clinical Data Manager
- Clinical Data Manager, Team Coordinator/Team Member
- Clinical Data Coordinator
Degrees
- MS
- Bachelor of Dental Surgery - BDS
By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy