Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs)
Provide guidance to junior members of the Data Management group
Develop, test and lock study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
Responsible for reviewing and contributing to protocols from a data management perspective
Manages the process from DMP development to data entry, data cleaning and data transfer, data lock to data export
Create Data Management Plans (DMP) and other data management documents for projects as required and manage the execution of all plans
Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
Creates data dictionary for data users
Manages the medical coding process internally or through external vendors
Develop, review and execute electronic data edit checks for web-based forms
Perform quality control (QC) on study data and programs as needed
Create, review, and process data queries and updates the databases
Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
Perform third party non-CRF data management activities, including data transfers and Serious Adverse Event (SAE) Reconciliation
Works collaboratively with other Pharmacokinetics staff, Biostatisticians, cross departmentally within BPSI to meet project deliverables and timelines for clinical statistical programming and reporting
Efficient collaboration with the team from vendors to ensure timely deliverables with high quality
Participates in and may lead process improvement activities within the department and cross functionally, including SOP development
Coordinate with the immediate supervisor or Manager Data Management to track and report status and progress of data management activities for allocated trials and be proactive to ensure smooth, successful and timely locking of databases
Serve as trainer/mentor for Data Management associates
May coordinate with Lead Data Manager/Senior Data Manager to ensure that assigned trials are managed efficiently with high quality
At least 3 years of experience in Data Management, performing activities in setup, conduct and locking of clinical data
BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
In-depth understanding of database structures and database programming
In-depth knowledge of CDISC standards, especially CDASH and SDTM
In-depth knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
Strong analytical and problem-solving skills
Must have strong communication (both verbal and written), interpersonal, and client services skills, be highly organized and self-motivated
Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
Ability to be flexible and adapt to change, to work independently, and take a leading and collaborative role in multi-disciplinary teams
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