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.

Preference:

Local candidates are preferred