Your Name

 Involved in writing and review data management plans and data validation plans.

 Ensuring completion of all activities leading to the study database lock.

 Ensures all activities in the Data Management Plan are completed.  Managed CRO’s work for Initiate, plan, and execute data management activities from study start-up to database lock.

 Performed vendor oversight and CRO management and also managed In-house projects.

 Worked on data review in support of data cleaning, quality control for operational study data in Medidata RAVE and other EDC databases.  Responsible for coding (MedDRA, WHO Drug Dictionary).

 Monitored data clean-up process performed by CRO’s from study start-up through closeout.

 Develop and test edit specifications which may include the development of test scripts used for and UAT testing.

 Performed UAT on different Medidata Rave bases by developing test scripts for each CRF Edit check.

 Reviewed query status reports and coordinated with different departments for unresolved queries. Testing for Oncology and studies.

 Performed and reviewed reports for SAE, Lab reconciliation.

 Was responsible for oversight design and development of Case Report Forms (CRF) in collaboration with CRAs or Clinical Project/Program Managers.

 Performed and monitored database lock activities as per protocol guidelines for Oncology studies.

 Ensured all data management activities are compliant with FDA standards, GCPs and SOPs.

 Responsible for timely initiation and completion of data Management activities for ongoing studies.

 Provided data management support to statisticians and data base programmers.

• Review electronically processed medical records received from sites, external third-party datasets, and other healthcare related data.
• Review and correct data exceptions based on rules developed to ensure data quality.
• Create moderate to complex business rules to identify data discrepancies.
• Review discrepancy output and correct data as necessary.
• Ongoing validation and maintenance of existing rule bases.
• Specify and create reports to assist the data review process.
• Query multiple data sources utilizing various technologies to address business needs and client inquiries.
• Report and analyze data output for internal customers.
• Assist in onboarding new data types from external sources into the data pipeline.
• Interact with data curation, management, and clinical staff as needed to assist in resolving questions and issues.
• Coordinate with third party data suppliers as needed.
• Participates in team meetings/ discussions as requested.
• Perform other Duties as assigned

• Oversight of all data management activities and deliverables on assigned clinical studies
• Manage and oversee CROs handling clinical data, including managing their timelines and budgets
• Work with CROs and Medical Monitors to coordinate activities for the medical review of clinical trial data
• Work with biostatistician and SAS programmers to ensure CDISC data standards (CDASH/SDTM) are implemented
• Provide review and oversight of database design, UAT, and deployment to ensure quality and efficiencies through data and process standardization
• Participate in cross-functional team meetings and communicate regarding project status/issues and timelines (including study database lock and data reviews), and provide feedback to CRO
• Oversee the development of data management documents (e.g., Data Management Plans, edit checks, data validation specifications, data transfer agreements)
• Lead interactions between MEI Pharma and external data vendors on the collection, transmittal, and transfer of clinical trial data; support review and reconciliation of external data; coordinates/leads SAE reconciliation
• Review clinical study protocols and statistical analysis plans and ensure data quality for data analyses
• Ensure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines, as they pertain to data management activities
• Manage competing data management priorities across multiple studies
• Work independently, exercise appropriate judgment, and coach other team members for effective communication
• Assessment of data management vendors
• Assist in the compilation of clinical data for regulatory submissions
• Previous experience in the management of budgets
• In-depth knowledge of all aspects of data collection and query resolution in clinical studies
• Strong working knowledge of GCP, CDASH, and CDISC data structures, 21 CFR Part 11, ICH guidelines, and FDA regulations
• Working knowledge of data management software (EDC, IXRS, ePRO, and other remote capture systems used in the industry)
• Knowledge of EDC systems(e.g., Oracle Inform, Medidata Rave), Argus platform, and general understanding/use of SAS
• Demonstrated capabilities and proven track record of problem-solving skills
• Excellent communication skills (oral and written) and interpersonal skills
• Ability and willingness to travel up to 10% of the time, including domestic and international travel
• Highly motivated team player willing to work and collaborate cross-functionally