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 guidance to the CPM at project start-up and throughout the study, in development of visit report annotations, guidelines, and assure efficient completion of visit reports by the CRAs:*Assist CPMs in the utilization of the standard annotations to limit unnecessary customization.*Collaborate with CPMs on training of SVR annotations, completion and submission per SOP.*Identify and track the project team compliance to SOPs for submission and approval of the visit report through direct communication with the CRA and/or if necessary their Line Manager.*Prepare and escalate issues noted in the site visit report which could impact subject safety, regulatory compliance and/or data integrity to the CPMs and CRA LM and/or Clinical Site Monitoring Quality Manager (CSiMQM), as necessary.* Review the visit reports to ensure identification and implementation of findings or focused site visit observations requiring corrective and /or preventative action plans.*Attend regular teleconferences with CPMs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs in a given project. Assist the CPMs with review of the trends emerging from the Issue Escalation Log.*Partner with the project team members to decrease the level of corrections/additions needed on reports by providing ongoing mentoring, coaching and better understanding of the SVR annotations.

*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.• Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF) • Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites. • Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial • Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.

• 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 authorities. Supervise staff in the operations of the department. • 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 protocols; recommend amendments to study protocols as appropriate. • 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 and drug accountability systems control. • 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.• Review protocol with the clinical team and ensure clinical team is aware of their roles and responsibilities.• Develop reporting mechanism for bringing critical and high priority issues to the investigators, study sponsors, and/or the monitors.• Develop an internal system for quality assurance.• Play a role in developing and implementing a recruitment plan to ensure long-term recruitment target is met.• Monitor enrollment and provide enrollment updates for the clinical team and the sponsors.• Develop, in collaboration with the investigators and site staff, the site-specific protocol documents and the informed consent document, with assistance from the sponsors.• Prepare appropriate individuals to disseminate information to health care professionals and the community to educate them regarding research activities.• Ensure timely and accurate transcription of information on source documents, paper case report forms (CRFs), and electronic CRFs.

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