Bhakti Patel

Responsible for managing and providing operational support to 10 clinical research sites in the west region. Responsibilities included developing and tracking site-specific quarterly goals, creating and supporting strategic and tactical plans for site growth, collaborating with the quality department to ensure protocol and regulatory compliance, and driving recruitment and marketing activities to ensure timely enrollment. Managing and directing the efforts of site leadership, including resource planning and forecasting, staff performance, corrective actions, and mentoring. Additionally, responsible for collaborating with internal key stakeholders, sponsors, CROs, and vendors to ensure that site performances are meeting the standards and expectations.

• Development and implementation of the regional business plan template across all regions.
• Implementation of the standard financial tools to support site leaders in better management of financial expectations.
• Implementation of site processes across all sites to ensure that the quality of the data is collected, and sites are audit ready.
• Implemented standardize tools to support with site relocation in compliance with regulatory and sponsor/CRO expectations.

Responsible for a comprehensive gap analysis of the existing quality management system to ensure adherence to study protocols, study-specific manuals, Glaukos SOPs, GCP guidelines, and applicable regulatory requirements. Developed and implemented a uniform quality management system for medical devices and pharmaceutical products. Responsible for identifying gaps in the current clinical SOPs and procedures against applicable regulations and GCP standards. Promoted a strong clinical quality infrastructure working in conjunction with key stakeholders by streamlining existing processes and creating new processes/tools to meet regulatory requirements and increase standardization amongst the team. Developed and/or facilitated internal/external audits and led cross-functional audit corrective actions seeing them through to completion. Ensured clinical teams are BIMO inspection ready. Responsible for the management of Clinicaltrials.gov for all ongoing clinical studies at Glaukos.

• Development and implementation of the organization’s Quality Management System (QMS), completing 20 SOPs/policies/tools revision in a 14-month timeframe. Continue to oversee and maintain the system and ensure compliance from organizational staff members.
• Developed an internal audit program and completed site and TMF audit including closure of all corrective actions in 4 months.
• Lead BIMO inspection preparation for 2 studies including completion of BIMO checklist, preparation of storyboard, ensuring all supporting documentation are readily available, and preparation of clinical team interviews in 6 months.
• Implemented infrastructure to manage clinicaltrials.gov registration, routine maintenance, and result submission per required regulation for about 20 ongoing studies and 30 completed studies in 2 months.

Responsible for planning, leading, supervising, and the management of the clinical operations and cross-functional team to support the successful movement of multiple projects through the clinical research process in accordance with ICH-GCP, SOPs, and applicable regulatory agencies. Worked with senior management and experts in the field to establish scientific methods for the design and implementation of clinical protocols, data collection systems, and final reports. Responsible for leading, coordinating, and executing all operational aspects of regional/global clinical studies from phase 1-3. Included recruitment and selection of clinical investigator, site and vendor contract negotiation, identification, qualification, and management of vendors, working with CMC and Clinical Supply Chain to ensure availability of clinical supplies at the sites, determination of study design, timelines/budget creation and management, ethic committee submission and approval, development and/or review of key study documents (i.e., protocol, pharmacy manual, study plans, DMC charter, CRF guidelines, CSR), oversight of recruitment/enrollment activities, management of TMF activities, and ensuring the study is audit ready. Oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported in collaboration with Medical Monitor. Driver of clinical research activities to complete studies on time and within budget including management of a clinical research team.

• Oversaw CRO, internal cross-functional team, external vendors, and consultants to ensure the timely database lock delivery for assigned trials. Included facilitating issue resolutions for study-related issues and ensuring processes as well as communication is streamlined.
• Contributed to the management of timelines and budget forecasts - overseeing trial activities leading to on-time close-out study activities for assigned trials.
• Audited CRO Trial Master File (TMF) for phase 2 study to ensure quality and accuracy of the TMF before database lock.
• Created patient profiles for assigned studies for data analysis and trending.
• Supported the development of CSR.

Responsible for providing oversight of study management and financials for regional and global clinical trials from initiation, and execution to closure. Responsible for managing resources (including internal, external, consultants, and vendors) to ensure the timely and cost-effective implementation of the clinical development plan for assigned programs. Collaborated with business development and co-development partners to ensure smooth and expedited execution of regional and global projects, including the formulation of the scope of the work and transfer of obligations. Accountable for the training and development of staff, monitoring consistent process application, and encouraging the sharing of best practices. Participated in the development and implementation of internal policies & procedures that aim to optimize the management of clinical trials. Responsible for the development and approval of site contracts, work orders, and invoices.

• Successfully led and implemented a metrics-driven system across all therapeutic areas to analyze and report study progress promptly and efficiently. Utilized existing Veeva Vault system to expand capabilities for project reporting. Created pathways, processes, and training plans to ensure successful implementation and follow-through.
• Developed 100+ proposals and budgets for new business opportunities. Developed presentation and study materials for bid defense meetings.
• Managed customer expectations and developed strong working relations through open communication, problem-solving skills, and constructive feedback. As a result, earned the sponsor partner’s respect and trust.
• Developed an effective team environment by providing mentorship and training to direct reports (project managers and clinical trial associates), resulting in project success and sponsor satisfaction.
• Created standardized meeting agendas and meeting minute tools across the therapeutic area.

Responsible for providing operational oversight and support for the conduct of the assigned clinical trial(s). Responsible for assessing operational feasibility to determine the probability of the study's success. Oversaw the assigned clinical operational staff/team involved in the design and management of the operational activities related to the planning, implementing, executing, and reporting of clinical trials in accordance with the sponsor protocol, scope of services, and contract. Served as the escalation point for the internal Ora team, external vendors, and sponsor, and provides clear communication pathways between involved stakeholders. Assisted with identifying risks and developing risk mitigation strategies. Responsible for hiring, mentoring, and training project managers and clinical trial associates. Participated and assisted in process improvement initiatives.

• Developed/defined clinical operation processes and procedures; developed trial master file naming convention, creation of Standard Operating Procedures aiding in standardization of processes, building efficiencies and consistencies across study teams.
• Contributed to the oversight of study conduct to ensure the data quality and timely delivery of trials within the approved budget.
• Developed standardized tools across therapeutic areas including timelines template, study plans (PMP, PCP, Monitoring), and staff training matrix.
• Contributed to identifying trial start-up and execution strategies for global projects.

Responsible for the overall execution of the clinical studies, achievements, and deliverables per project plan and customer (sponsor) scope of work. Drives all aspects of the project management process from initiation, planning, execution, control, and closure to ensure that projects are conducted in accordance with GCP and SOP guidelines. Included creating and managing timelines and budget, resource management, building effective relationships with all stakeholders, site, and vendor selection including the execution of the contracts, clinical supply planning, ethic committee submission and approval, development of study plans, review and approval of EDC build and edit checks, site activation, internal and external staff training, risk assessment and mitigation, management of study reports (financial, project, etc.), timely escalation of project related issues to management and sponsor, facilitate and prepare materials for meeting and review of Trial Master File (TMF) to ensure accuracy and timely completeness. Participate in proposals and bid defense as requested by management. Mentor project managers and clinical trial associates.

• Successfully initiated, executed, and closed the first global project. The study was challenged by internal staff turnover, lack of global policies, patient compliance, recruitment hurdles, and completion of enrollment in a shorter period that resulted in a shortened data collection deadline. Through effective communication, maintaining a positive rapport with the team, the development of a tool to project subject visits and monitor visits, and the implementation of a contingent plan to rectify patient compliance and recruitment strategies led to no subjects were lost and the last CRF was retrieved as projected and project a success.
• Working with cross-functional teams to build global processes to ensure smooth trial execution.
• Successfully initiated two studies in start-up with demanding clients and timelines resulting in meeting on-time delivery for both studies and sponsor satisfaction. This was achieved by close communication, proactive risk assessment and mitigation strategies in place, managing project recruitment and progress closely, and most importantly keeping a cheerful attitude and continuance in illustrating a commitment to the sponsor
• Line managed, mentored, and trained both clinical trial assistants and Project Research Associates which resulted in more responsibilities and promotions to higher-level positions.

Responsible for driving all aspects of the project management processes including but not limited to project initiation, planning, execution, closeout, and risk management/contingency. Coordinated activities and deliverables for all project partners (e.g., internal cross-functional team, external partners, sponsor) and proactively identifies and manages issues. Required to line manage other project management team members and manage cross-functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s). Responsible for timeline creation and resource planning required for the study. Responsible for budget and timelines maintenance. Created and/or reviewed study plans and study-related documents created by the functional lead. Responsible for periodic (weekly, or as needed) internal and external study team meetings. Reviewed study metrics for performance and quality with the team and management. Managed cross-functional teams and third-party vendors involved in the study to ensure on-time project delivery. Served as a primary liaison between clients, stakeholders, and the study team.

• Successfully led the study team in a fast-track start-up of the first global study run at Ora resulting in meeting the target of the first patient screened within 6 weeks of study implementation. Identified ethic committee, regulatory approval, and business/contract requirements for global study in advance to avoid any delay in study start-up.
• Utilized positive work ethics and reinforcement by being a team player and developed relationships that resulted in creating a positive work environment and motivated team members to meet project objectives.
• Participated in process improvement that resulted in the overhaul and institution of a global standard template used by project managers for senior management monthly project and financial reviews and assisted with training of colleagues in the use of the template.

Managed operational and financial aspects of regional and global clinical studies/programs including multiple third-party vendors from initiation to closure and ensured study teams followed SOPs, regulations, and agreed-upon contractual requirements cost-effectively. Responsibilities included overseeing feasibility assessments, timelines/budget creation and management, ethic committee submission and approval, site selection and contracting, development/review of key study documents, essential document review and approval processes, resource utilization and proper allocation, ensuring adequate staff training, and TMF review and maintenance.

• Recipient of business unit SPOT award for commitment to excellence and exceeding company and sponsor expectations for having to identify risk and instantly coming up with a mitigation plan to avoid timeline delays for the first patient screened.
• Provided high-quality customer service by meeting on-time deliverables and developing a high level of trust with sponsors that resulted in repeat business and sponsor requests by name.
• Successfully initiated, executed, and closed a large scale 80 US center, fast enrolling study consisting of about 1000 screens and 700 randomized subjects. The study was challenged with internal staff turnover, demanding client expectations, vendor initiation, and completion of enrollment in a shorter period that resulted in a shortened data collection deadline. Through effective communication, maintaining a positive rapport with the team, analyzing study reports and progress closely led to sponsor satisfaction.

Responsible for providing oversight to Marketing, Recruitment (site and international Call Centers), Clinical Trial Conduct (CRCs and CRTs), and Screening Departments. Analyze study strategies for the feasibility of recruitment, enrollment, retention, clinical conduct, resources, and timelines. Participated actively in Site Qualification Visits, Sponsor Audits, FDA Audits, bid defenses, departmental meetings, and Internal Audits. Monitored monthly/yearly departmental budget and recommended actions to improve cost efficiency. Analyzed operational and technological needs of the department and recommended implementation of new tools and resources to improve work efficiency, workflow, and overall study conduct.

• Received Leadership Award in Dec 2014 for leading and mentoring teams.
• Created and implemented a goal-oriented system for Recruitment and Marketing to increase successful subject enrollment.
• Created and implemented a centralized dosing schedule to increase the efficiency of study conduct by 50% for the Clinical Trial Conduct, Pharmacy, Laboratory, Investigator, Support Staff, and Scheduling Departments
• Successfully coordinated and hosted a site FDA audit without any findings.

Managed, restructured, and expanded the Clinical Trial Conduct, Clinical Support (RNs, LVNs, MAs, CPT), Scheduling, Lab, and Clinical Trial Administrator Departments. Assessed operational feasibility to determine the probability of study success including risk mitigation. Monitored relationships/processes with sponsors, auditors, CROs, IRBs, laboratories, independent vendors, medical professionals, and investigators. Worked closely with Project Managers to ensure that the sponsor's goals, timelines, cost, and quality performance are met in the conduct of all clinical trials. Facilitated site qualification, Sponsor and FDA Audits, client tours, internal audits, management meetings, and quality assurance.

• Received President Award in Dec 2012 for exceeding the company’s expectations.
• Initiated and implemented Standard Operating Procedures (SOPs), work instructions, and study templates for all company-wide departments.
• Developed annual department budgets to manage department costs and resources.