Deval Bhavsar Email & Phone Number

Lawrenceville, New Jersey, United States

Help drive accountability and delivery of all country clinical operations team commitments within Americas region for assigned trials throughout the end-to-end study lifecycle by coordinating between global and local teams. Drive the clinical trial feasibility process and decision-making for country, site, and patientallocations on behalf of Americas region in collaboration with global and country heads. Monitor and drive country-level timeline planning and sequencing of events in assigned region during study start-up within Americas region. Synthesize learnings from trends surfaced from regional monitoring throughout studyconduct and leads patient re-allocation decisions as needed.

Princeton, New Jersey, United States

• Supervise and coordinate the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs) and Clinical Trial Associates (CTAs) to ensure timely execution consistent with R&D and local research goals and priorities• Anticipate resource needs and provides workload evaluations and task assignments• Allocate and assign study resources in alignment with R&D and local research goals and priorities.• Supervise clinical trial execution at country level including supervising study metrics and team performance• Approve study fee funds and payments based on grant of authority• Propose and/or validate country study targets• Support Health Authority inspection and pre-inspection activities• Support audit preparation & Corrective Action /Preventative Action preparation for local related issues• Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available• Develop goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met• Together with the RCO management track and manage performance metrics for Clinical Operations staff• Point of Contact for FSP & FTE staff within the country• Managing the hiring, performance management and succession planning of staff• Performing general and human resource administrative functions• Participation in performance calibration and talent review meetings• Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)• Represent Regional Clinical Operations team in local leadership discussions at the affiliate level and be member of the local affiliate leadership team• Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations & Heath Authorities

Decentralized, Nj

• Monitor Clinical Research Associate staff performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence is accurate and complete.• Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables.• Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan by conducting quality check of deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action.• Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.• Manage and develop the staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring and allocating staff according to their ability.• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, PAREXEL SOPs, and where applicable, sponsor SOPs.

Decenrtalized - Nj

• Schedule, plan, prepare for and then perform site monitoring visits according to the monitoring plan and SOPs to ensure appropriate monitoring activities are completed at each onsite or remote visit (e.g. SDV, site staff training, investigator site file review, compliance checks, drug accountability, observational visits, facility review, etc.)• Review subject safety data and AEs/SAEs and ensure appropriate follow up and escalation according to protocol/regulatory requirements.• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.• Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required.• Support less experienced staff with on-site preparation of audits and inspections as requested by LM.

Decentralized - Nj

United Kingdom

• Performing the Clinical Monitoring aspect of designated projects in accordance with Parexel SOPs, ICH GCP guidelines and Local UK regulations.• Conducting on-site study specific trainings and performing site facilities inspection. Performing On-site Clinical Monitoring activities (drive patient recruitment, source data verification, Drug Accountability), checking regulatory documentation, performing Qualification, Initiation, Monitoring and Termination of Investigational Research sites in accordance with ICH GCP guidelines.

Uxbridge, Uk

• Take responsibility of various study specific tasks and train project team members on selected tasks.• Creating and distributing the research study documents; management of drug supply to the site.• Perform regular reviews of the study data according to the Monitoring guidelines (Conducting remote study site visits: Initiation, Monitoring & termination).• Build relationship with the Investigators and study site staff remotely; and resolve site specific study issues promptly.• Review study recruitment plan and enrolment updates.

Croydon, United Kingdom

• Assist CQM in creating Clinical SOPs/Adhoc documents and to ensure that all staff are familiar with all relevant SOPs, Research Study protocols and ICH-GCP Guidelines.• Take lead in assessing staff in action ‘providing on the job training’ as possible and intervene whenever necessary to minimize error.• Assist CQM to re-assess Clinical staff competence at regular intervals and taking interviews.• Deputize for the CQM in her absence; Liaison with other functional departments to ensure smooth conduct of Phase-I Clinical Trials. • Perform spot QC checks of the Screening and Study CRF.• Liaise weekly with the training Manager to identify any outstanding training issues and incomplete delegation records and seek to rectify by appropriate means.

• Liaison with Research physicians, Study Managers, Project Managers and Research nurses to plan and smooth execution of the Clinical trials for First in Human studies.• Data QC, Logging, Maintenance, Query generation and resolution via eMDF (Electronic monitoring Discrepancy form) of the Screening/Rejects and study CRF.• Performing Clinical procedures on volunteers pertaining to specific studies as and when required in accordance with ICH-GCP guidelines.• Scheduling department duties: Assigning Clinical tasks to Research Physicians and other Clinical staff on weekly basis.

• Scrutinizing various high risk life insurance applications based on the medical reports and granting approvals for the same.

Msc, Pharmaceutical Sciences

Activities and Societies: Thesis: Developed novel bi-layer tablet for Rifampicin and Isoniazid for improvised bioavailability.

B.Pharm, Pharmacy