ICON Hiring Group Leader / Manager / Sr Manager for Data Management
Job Location : Chennai
Job Description
- Allocate resources to projects to ensure project objectives are maintained.
- Provide regular status reports to Senior Management.
- Understanding of CDM functions, programming and SDTM process .
- Provide SAS programming expertise in producing SDTM, ADaM, Tables and Listings from clinical trial data
- Ensure projects are conducted in accordance with internal SOPs, client requirements and Good Clinical Practice (GCP).
- Liaise with the client, Biostatistics Manager and the Clinical Project Managers to ensure overall project objectives are met in an efficient manner.
- Provide input into cost proposals, client presentations, development of new systems and processes, as required.
- Attend project meetings and meet and communicate with clients, as required.
- Ensure adequate processes are put in place in response to deviations in data quality, timelines and/or budget.
- Provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines and any other study related documents, as required.
- Provide advice on data management and/or data transfer processes as required.
- Co-operate with Data Management Training Co-ordinator to ensure the training needs of all Data Management staff are identified and addressed on an ongoing basis.
- Provide regular feedback to data management staff on their performance and instigate follow up review where required.
- Keep Data Management Training Co-ordinator advised of all training requirements identified during staff assessments.
Requirements
- 10 years of relevant experience in CDM functions
- SDTM Programming experience is mandatory
- Excellent written and verbal communication skills