Location: Neelavara, Udupi, India
Position: Full-time, permanent
Main Job Tasks and Responsibilities:
The Biometrics Project Manager will be responsible for the Management of the Biometrics Division project related activities to ensure a clean database, timely delivery of protocol, randomization, CRF, statistical output, meeting the required quality level, within agreed timelines and budgets.
- Act as Biometrics Project Manager, while having a sound Data Management background
- Perform Project Manager duties for all Biometrics Division activities, including project set-up, initiating and chairing project team meetings, project planning & coordination, project review and reporting, while ensuring appropriate quality of deliverables within agreed timelines and with control over the available budget
- Perform project related communication with internal and external clients to guarantee sufficient exchange of relevant information and to maintain good client relationship
- Facilitate the standardization of tools and processes in the department
- Support the Data Management Department by performing delegated line management tasks for Data Managers. This may include training and coaching of junior staff, defining/implementation/follow-up of training plans.
Education, Experience, and Skills:
- Minimum degree in Science, Master degree will add value.
- Minimum 5 years of experience in Data Management (Study Start-up/ Study Conduct/Study Close out activities).
- Practical experience in managing all Data Management activities within the conduct of all stages of a clinical trial or clinical investigation
- Experience in Project related Documentation, SOPs.
- Experience in System Demonstration and User Training.
- Excellent knowledge of Data Management workflow and the relevant guidelines for the conduction of clinical trials (e.g., ICH-GCP)
- Good understanding of the statistics workflow in clinical trials
- Good knowledge of clinical trials
- Excellent knowledge of EDC tools in the setup, conduct and closure of clinical studies and clinical investigations
- Able to write and speak English with good communication and comprehension skills
- Good time Management Skills.
Local candidates are preferred