Job Description:
Responsibilities:
Additional Info:
Functional Area : Data Management [Click Here to Access the Original Job Post]
Responsibilities:
- Accountable for the quality and timely delivery of all programming deliverables for multiple studies in one or more clinical programs, to support data capture, processing and data provision. Includes leadership & oversight of other programmers responsible for deliverables in the program.
- Utilizes Clinical Data Management software and other supporting tools to design, write, validate, and maintain programs to meet specifications in a quality, timely and productive manner following standard development procedures.
- Generates and maintains all required documentation, including the development of specifications, coding, and validation efforts in support of Case Report Forms (CRFs), database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and reporting.
- Manages resources on their program(s) and seeks help as required.
- Acts as a technical Subject Matter Expert (SME), supporting clinical programming and data management staff in their effective use of Electronic Data Capture (EDC), reporting, and processing tools.
- May lead one or more functional areas, for example, Database Development, External Data Integrations, Extract Transform Load, Global Librarian/Standards, Training, Documentation, SDTM mapping support, etc.
- Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations, and implementations.
- Assists in monitoring internally and externally hosted applications for performance and/or system errors.
- Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.
- Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle, MDSOL Rave, CRF, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions.
- Serves on program teams to coordinate and lead development activities for clinical programming projects.
- Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism.
- Actively looks for and promotes process improvement opportunities and adopts an innovative mindset.
- Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and proactively escalates potential problems, including resourcing, Assists in sponsor and internal audits, and regulatory inspections
- Monitors the scope of work to actual work, alerting management of potential change orders. Manages and executes the change order to completion. Provides input and supporting details for change orders.
- Provides training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications, and uses expanded technical skills to meet evolving project needs. Seeks help when required.
- Seeks to expand their overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc.
- Collaborate with project and functional leadership to ensure project delivery and GCE Data Management strategic success.
- Assist in project meetings and actively contribute and participate in departmental review meetings.
- Attend Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned duties.
- Collaborate with Auditors as required as the Lead programmer of the program
- High proficiency in Programming languages in CDMS like SAS and SQL Plus and good knowledge of data standards, e.g. CDISC
- Strong computer skills with proficiency in Medidata Rave or any other Data Management system.
- High proficiency in Clinical Data Management procedures including good knowledge of Good Clinical Practices (GCP), 21 CFR part 11 and other regulatory requirements
- Strong organizational, influencing, presentation, documentation, and interpersonal skills as well as a team-oriented approach.
- Significant, demonstrated experience with clinical programming; clinical data management; CRO industry; Electronic Data Capture (EDC) systems and data reporting; along with languages such as SAS; C#;
- Demonstrated ability to consistently produce quality deliverables.
Requeriments :
Skills :
Areas :
Additional Info:
Functional Area : Data Management [Click Here to Access the Original Job Post]