Birva Shah

• Overseeing Startup activities and advising CROs for the Site recruitment, Country Selection, Study Start-up, and Contract/Budget activities • Provides input and recommendations to SOPs, Working Guidance, and Job Aides related to SSU systems • Proactively identifies areas for process improvement; brings consistency across studies, leads functional area continuous improvement projects, and suggests solutions to mitigate deficiencies and enhance processes • Provides audit and inspection preparation support for SSU-related deliverables; involved with inspections/inspector interviews as needed • Collaborate with Regulatory, Clinical, Project Management, Therapeutic Heads, Finance, and other departments/stakeholders in implementing strategic company goals for the team • Participates in technology initiatives and vendor selection related to startup systems

• Provided immediate oversight for the SSU performance and teams within the assigned regions. • Managed staffing and resources to ensure departmental utilization of SSU teams • Partnered with VP to determine, improve, streamline, and apply global efficiencies and processes for SSU • Managed and responsible for the expansion of the SSU team in India– Site Activation Packet reviewer, file maintenance, and ICF country adaptation team • Closely collaborated with the SSU mgmt. Within the US and in other regions to work towards the same goals and objectives in a consistent manner • Ensured that the SSU process is proactive and completed according to contractual agreement • Recognized strategic opportunities to improve department productivity, including recommending measures to reduce costs • Contributed to aspects of business development, including evaluating and defining proposal specifications • Participated in departmental metric reporting monthly • Met with management staff regularly to ensure that studies are on target to meet contracted timelines • Performed all aspects of managing/mentoring direct reports for training, performance management, and career development • Drafted and advised on all applicable SOPs, Working Guidance, and Forms s related to SSU

• Directed the Leadership Team in the performance of the SSU and File Maintenance staff. • Worked with the Leadership team to implement QC/QA processes that effectively provide our internal and external teams with high-quality deliverables. • Overseeing 60+ associates & 4 Managers in India and 25+ associates & 3 Line Managers in NA, which includes hiring, training, resourcing, maintaining >85% utilization, and metrics reporting. • Developed training curriculum for NA, EU, and Asia staff. Ensured staff compliance with training requirements. • Managed and responsible for the expansion of the SSU team in India– Site Activation Packet reviewer and ICF country adaptation team • Directed the development of study start-up and File Maintenance Review plans. Ensured team members incorporated the required elements of the Regulatory Plan and Clinical Monitoring Plan in accordance with Good Clinical Practices (GCP). • Participated in developing department budgets and is accountable for the profit/loss of functions carried out within the dept. • Developed study budgets and text for the SSU and File Maintenance components of proposals in conjunction with the VP of Operations. • Responsible for resource and financial forecast within the variance of <2% for 20+ studies. • Ensured that SSU and File Maintenance functions interface effectively with Novella's other key operating departments. Facilitated and participated in the SSU-Regulatory and SSU-Clinical Monitoring department collaboration meetings. • Participated in business development activities to grow Novella business. Attends Bid-Defenses, Client Alignment, and Kick-Off meetings. • Worked with the leadership team and VP of operations to continually identify leading-edge initiatives that support Novella’s overall strategic goals and profit objectives. Serves as a department representative for the new eTMF, Site Portal, expanding team overseas, PI Database, and improved Time to Open-Startup timeline.

• Supervised 10-17 associates, including resource selection and hiring, performance training and oversight, timesheet review and approval, and team collaboration activities. • Communicated with sponsors and the project team to prioritize sites to be focused on for activation, managed study timelines, and helped the team set start-up goals. • Led the development of site qualification questionnaires and protocol review, drawing on medical knowledge and regulatory expertise, to interview sites for potential involvement in studies or trials. • Oversaw an ongoing QC process and periodic investigator site file audits to ensure compliance with GCP and Novella’s standard operating procedures. • Ensured team members understood budgets for the studies they were working on and were accountable for notifying Project Managers when additional activities may cause budget overages. • Participated in proposal preparation and bid defense activities. Participated in alignment and project kick-off meetings. • Worked with several vendors for new technology initiatives. • Trained and mentored new employees in implementing the tasks and responsibilities within their job description. • Author of several standard operation procedures and working practices for SSU and File Maintenance. • Participated in the development and implementation of critical organizational process improvement initiatives. • Initiated and deployed 55+ resources in India for Study Startup, Site Payment, Site Identification, ICF reviewer, and File Maintenance teams.

•Worked with ISSC Management to discuss projected hours for projects and scope of work. •Led start up activities and served as Novella representative in interactions with the sponsor. •Served as a team trainer and mentor as new projects were awarded. •Documented study challenges and reported them to the ISSC Management or Project Manager. • Identified out of scope activities and reported to Project Manager and team and assured that such activities do not begin until the client provided authorization. •When escalating complex requests, recognized underlying issues and communicated as appropriate. •Created and disseminated Confidential Disclosure Agreements (CDA)/ Questionnaires to sites and followed up accordingly to ascertain interest and to meet study timelines. •Created templates for regulatory documents specific to local and central Institutional Review Board (IRB) submissions. •Collected and reviewed regulatory documents for completeness and accuracy. •Reviewed Informed Consent Forms or led this process and follows up with sites and sponsors accordingly.

•Performed initial qualification visits of potential investigators. Evaluated the capability of the site to successfully manage and conduct the clinical study. •Coordinated activities with the site in preparation for the initiation of studies. Worked with the Study Start-up group to obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. •Performed study initiation activities, reviewed protocol with PI and site personnel, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities. •Assured adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performed validation of source documentation as required by sponsor. Prepared monitoring reports and letters in a timely manner using approved Novella/sponsor forms and reports. •Documented accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performed investigational product inventory. Ensured return of unused materials to designated location or verified destruction as required.

•Assisted in preparing Master Services Agreements for new sites. •Worked closely with project managers, clients, sites and Novella legal counsel to manage and execute Investigator Agreements and negotiate Investigator budgets. •Provided weekly updates to client on Investigator’s contract and budget. •Prepared budget template based on protocol schedule of events. •Assisted projects managers with the preparation and negotiation of consulting and vendor agreements and budget.

•Supported sponsor Study Management by providing study start up, contract & budget negotiation, maintenance and close-out activities for assigned studies. •Trained and mentored entry-level or new staff as directed. •Coordinated workflow, staff and tasks to accomplish study or project deliverables as requested. •Coordinated the preparation and the routing of clinical study agreements and ensure that fully executed agreements are in place prior to drug shipment and payment. •Traveled to sites and/or CRO’s to conduct file review, reconciliation and other closeout activities as requested.

• Performed site management through performance and documentation evaluation. • Performed in-house and on-site monitoring for all types of study visits. • Responsible for monitoring all sorts of clinical trials, assure adherence to Good Clinical Practice, investigator integrity and compliance with all study protocols. • Therapeutic focus: CNS

•Responsible for the operational implementation of clinical development trials from study start up to completion. •Processed regulatory documents, site contracts and informed consents. •Created and negotiated study related Per Subject Budget. •Served as point of contact for questions related to protocol, invoices, queries resolution for internal and external customers •Responsible for accuracy of several databases systems (e.g. CRF, Subject visit tracker, Budget Update, Study Timelines, Patient Recruitment Update).

•Responsible for patient screening, recruitment, and enrollment for research projects. •Supervised patient care for all study patients. •Performed audits for each study (10% of files) on a regular basis to eliminate any performance, legal or compliance issues. •Organized all patient source documentation and regulatory information (Case Report Forms). •Conducted monitoring and initiation visits with Contract Research Organizations and Pharmaceutical Companies.

Master of Healthcare Administration