Bharti Dabas Email & Phone Number

Canada

Toronto, Ontario, Canada

• Lead SSU team or service line in all activities during start-up phase. Monitor team efficiency, quality and adherence to project timelines, budget, SOPs and WPs. • Develops, with the input of regulatory and contracts, a study specific SSU plan.• Communicates overall site activation status to internal teams and sponsor.• Directs the process for the selection of study sites and investigators.• Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators. • Works with sponsors and internal team members to establish regulatory requirements and contracts. • Provide work instructions to team members. • Directs the development of study start up review plans.• Developing appropriate early warning systems of potential obstacles to the successful completion of the project.• Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.• Reviewing and identifying project study trends and proactively responding to client and respective team members. Provide feedback to management on site performance metrics.• Implement and manage a risk-based approach to all activities, identifying potential obstacles to the successful completion of deliverables and developing innovative solutions to challenges.• Provide directional insight for Change Orders and Out of Scope work. Responsible for management of project timelines ensuring activities are completed by the timelines agreed. • Assist study management team with continuous planning of work completed versus ongoing requirements which will feed into the overall budget management of the study.• Prepare and QC study start-up data reporting to internal teams and/or Sponsors, including InfoStart reports, SAPT reporting, reporting on country / site status.

Toronto, Ontario, Canada

•Manage research activities for clinical projects in Canada, including study start‐up, active phase, monitoring, analysis, and closeout; ensuring compliance with study protocol and regulatory requirements.•Provide leadership to local study team and provide training and ongoing support to all participating sites.•Supporting local feasibility and investigator selection. Leading study start-up activities, subject recruitment and retention planning at the country level, timely acquisition of quality data and trial documentation.•Coordination with finance department for handling of Canadian study payments, spend and forecast management. •Responsible for submission of regulatory documents to regulatory bodies including Health Canada. Eg: CTA, CTA-N, CTA-A, import permit, exemption applications for controlled substances, etc. •Manage and coordinate the shipment and import of IP to Canada, oversight of all regulatory paperwork related to import. •Responsible for reviewing or preparing a clinical monitoring plan along with Identifying, assigning and monitoring the completion of interdisciplinary project tasks that include site monitoring, CRF and database development and revision, data collection, patient safety/AE management, document management, statistical analysis, final report writing and publications.•Develop and/or participate in the development of project communications, training, regulatory submissions and/or audits and selection of third-party vendors as required.•Conduct monitoring visits: to ensure site compliance and adherence to study protocol and applicable regulatory guidelines (Health Canada, FDA, ICH‐GCP, etc).•CAPA plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution•Ensuring Trial Master File (essential trial documents) is complete and up to date to support audit and inspection ready.•Accountable for write progress reports for funding agencies & meeting study milestones.

Toronto, Ontario, Canada

•Manage and maintain a controlled records management system for eTMF and related clinical trials.•Prepare and maintain administrative logs and trackers including Regulatory Documents collection & eTMF tracker. FDA and Central IRB submission tracker, IP shipment tracker., etc.•Liaison with clinical trial sites CRO and internal study team to facilitate the collection filing and tracking of regulatory documents and other related study documents including MVs.•Prepare study and site level Regulatory ethics submissions and attain Regulatory ethics approval including but not limited to Initial Ethics and Renewal submissions, SAE Reports submission, protocol deviation submission, study advertisements submissions, etc.•Participate in vendor selection process through the completion of request for proposals (RFP) and the negotiation and management of external vendor contracts.•Prepare regulatory packages and study start‐up binders and tools for the clinical trial sites and coordinate shipment of trial materials, equipments and supplies to clinical sites.•In co‐operation with Quality Assurance, complete IP over labelling procedure as per study protocol requirement and coordinate shipment of IP to investigative sites and 3PL.•Supporting local feasibility and investigator selection. Leading study start-up activities, subject recruitment and retention planning for all sites across North America, timely acquisition of quality data and trial documentation.•Coordinate site trainings with study CRAs & clinical site coordinators(e.g., Protocol related training, technical training, eCRF training, SIV, etc.)•Responsible for organizing and planning monthly management overview meetings, clinical meetings, Advisory Board meetings, etc.•Lead the set up and execution of multicenter trials, assisting in site identification and qualification.•Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable.

Toronto, Ontario, Canada

•With the principal investigator, plan and establish operating procedures for various clinical and research activities within the studies.•Assist investigators in the initiation of new research along with interpretation and implementation of study protocols.•Represent institution at protocol development and study initiation meetings IRB and Health Canada•Assist in preparation of REB, IRB, and Health Canada submissions.•Plan, implement, and coordinate all aspects of data collection and source documentation, responsible for data entry using study databases.•Oversee study medical records, collection, and transcription of study‐related data, overseeing the tabulation of study related data as required.•Assist in the development and maintenance research activity records, including finances (i.e., budget, invoicing, stipends)•Ensure timely delivery of clinical trial enrollment. •Point of contact for research participant questions and concerns.•Educate participants as required re: treatment schedule and/ or the use of data collection tools.•Collaborate with investigators, clinic staff, physicians, and other clinicians to recruit study participants (e.g., identify and screen potential participants, obtain informed consent, conduct pre‐testing)•Administration of the Letter of Information and Consent Form to study participant.•Collecting data via phone calls, interviews, administering study questionnaires, conducting interviews•Execute aspects of study visits (i.e., documentation of adverse events and medications, etc.)•Main point of contact for patients and healthcare providers enquiring about a particular study.•Prepare for study monitor visits, liaise with study monitors and work to resolve outstanding issues/problems in a timely manner.•Assist with preparing for audits.•Maintain all regulatory files and essential documents for research studies including eTMF and ensuring their completeness to support audit and inspection from FDA and Health Canada.

Toronto, Ontario, Canada

•Supporting the Genomics team for the development and implementation of a robust genomics program to monitor genomic changes and rapid detection of emerging variants of pathogens of Public Health Significance for Ontario.•Ordering supplies and maintaining inventory duties for the Research and Development department.•Management of orders and invoice payments, order requests, purchase requisitions, cost transfers, budgeting, etc.•Participates in detecting, reporting, correcting, and preventing unexpected occurrences, identifies opportunities for •Participates in continuing education activities and performed other duties as assigned according to training and scope of practice.•Act as primary liaison throughout the project life cycle ensuring client/sponsor expectations is appropriately managed by addressing and resolving queries/issues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsor/client with project status and update reports.

Toronto, Ontario, Canada

• Development and Implementation of a comprehensive Social Media Best Practices Guide that is suitable to the intricacies of the business, specific social channels and applicable strategic goals.• Creation of LinkedIn page for the organization, including a comprehensive content strategy for the year, ongoing content calendars, serving as the assignment & copy editor for 2 writers, while supporting the Human Resources Recruitment team in their use of the platform.• Establishment and implementation of an efficient content creation process flow from creation to publication that includes source verification, plagiarism checks, editing and distribution.

Toronto, Canada Area

•Working with website Core Content Team for Brain cancer project, evaluating, creating and publishing technical, health and lifestyle information which the organization will provide to pets and their families experiencing cancer diagnosis, treatment and palliative care.• Research, evaluate and contribute technical, health and lifestyle cancer content to be published by the organization.• Research, write and edit materials for Pet Cancer A-Z for the PCF website.• Participate in discussions regarding writing style, tone, listing of citations and sourcing relevant pet cancer information.

Markham, Ontario, Canada

• Preparing and delivering engaging biology lessons to students from different backgrounds with different interests and abilities.• Instruct students in large classroom settings as well as small groups to expand knowledge of scientific method and biological sciences.• Monitoring student performance, and adjusting teaching strategies and techniques for improved content delivery.• Setting up exams, assessments, and experiments in accordance with curriculum requirements.• Guide students through the process of discovering their interests and choosing college profession by helping them assess personal skills, interests and values, and cultural influences and articulating these in a professional setting.• Encourage active participation and monitor individual student performance to enhance their understanding and master skills.• Communicating any student issues to parents, counselors, and other relevant staff members.• Attending school events, club meetings, and staff meetings as required.• Coming up with suggestions to improve the Biology Department and general school operations.• Building rapport with students so that they feel comfortable and safe discussing sensitive topics in class.• Encouraging students to participate in science fairs, competitions, and expos, and preparing them for these events.• Communicate with students and parents through conferences, telephone calls and email about student performance, goal setting, and other issues.

New Delhi Area, India

• Responsible for in silico experiments and data analysis using Discovery studio, cytoscape softwares andanalytical analysis of more than 50,000 genes and chemicals using databases like CTD and GIANT-netwas• Managed lab operations for testing.• Communicating and coordinating with other researchers on experimentation and results interpretation.• Assisting scientists and fellow scholars in writing and editing research papers and manuscripts for publication• Making timely progress report for the project and submission of research progress report to the scientificboar

New Delhi Area, India

New Delhi Area, India

Drug Development

New Delhi Area, India

Graduate Certificate, Professional Writing And Communications

M.Sc., Biotechnology

Graduate Diploma, Dietetics And Clinical Nutrition Services

Bachelor Of Science (B.Sc.), Biotechnology