Biswadeep Saha Email & Phone Number

Bengaluru, KA, IN

India

India

Bengaluru, Karnataka, India

Bangalore

*Manage a caseload of visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. *Review assigned visit reports in order to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs.* Provide.

*To perform SSV, SIV, monitoring activities and close out for different sites.*To train CRA for different topics through different sessions.

Bangalore

• Managing and maintaining study files and documentation ensuring high levels of accuracy.
• Logging and tracking of study documentation and trial progress and recording dispatch of study supplies.
• Arranging and attending internal and external meetings, assisting in the production of presentation materials, generating meeting minutes.
• Contacting external and internal individuals to collate relevant study information and assist with study payments.
• Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.
• Preparing Protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.

• Supervise, plan and coordinate the clinical supplies activities within the clinical trials research projects conducted by principal investigators as well as external facilities.
• Ensure that goals and objectives of projects are accomplished within established time frames and budget guidelines. Ensure compliance with Good Manufacturing Practices and applicable state and federal regulatory.
• Participate in protocol review to identify clinical issues; establish time frames; develop budget projections; identify procedural and administrative issues; contribute to the ongoing analysis and modification of.
• Supervise the activities of staff assigned to study to resolve issues including, but not limited to, labeling, packaging, distribution of clinical trial supplies, development and maintenance of clinical trial database.
• Participate in staff selection and provide feedback to employees' supervisor on a routine basis regarding team members' performance.
• Provide oversight of domestic and international clinical supply shipments. Communicate with trial sponsor as needed.

• Play an integral role in managing the overall site staff; this involves human resource and logistical issues.
• Oversee overall clinical operations related to conduct of the trial (i.e. recruitment, informed consent procedure, visit coordination, sampling, visit scheduling, etc).
• Work in collaboration with study team to ensure trial preparedness.
• Attend and participate in investigator’s meetings, stakeholders meetings, and other meetings as needed.
• Serve as point person at the clinical site for monitoring needs. Prepare monitoring visits to make sure monitors receive all necessary information during their visits.
• Organize and participate in the site initiation visit and accompany the monitor during monitoring activities.

M.Sc In Clinical Research, Clinical Research

Post Graduate Diploma, Pharmaceutical Management (Pgdpm)

B. Sc, Biotechnology

Puc, Physics, Chemistry, English, Biology,Maths

Ten, English, Physics, Chemistry, Biology, Bengali