Sr. Project Manager- Clinical Operations and Regulatory Affairs - Leszarians - Chennai
(2013-03)
- Responsibilities in regard to resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements within the Clinical Operations group at country level.
- Leading the overall delivery, through your operational team, to drive execution of service, client satisfaction, quality and efficiencies.
- Managing a team of CTAs and CRAs.
- Input to Director on budgeting discussions for your team to drive productivity and quality within the region.
- Working as a key project lead on process improvement, efficiencies and technological development to enable to group to deliver on its year on year targets.
- Working across peer group to develop key people processes, success to be implemented into the region.
- Lead key initiatives at the manager level across the clinical operations group to ensure best practice and continuity services.
- A key contact for the Sponsors in regard to operational questions and escalations.
- Working on initiatives led by functional heads of CRA monitoring to support global consistency, focus and development across their remit.
- Drive innovation and continuous improvement in all areas of responsibility.
- Conduct regular 1:1 discussions with direct reports and lead team meetings at country and manager team level.
- Act as country level client liaison.
- Represent Clinical Operations at Sponsor and internal audits.
- Recognize, exemplify and adhere to Leszarians values around our commitment to People, Clients and Performance.
- Recognize the importance of and create a culture of continuous improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
- Provide effective management support through your team to deliver a high performing culture including managing attrition, development and engagement of the operational group.
- Carrying out all relevant line management responsibilities including appraisals, goal setting and development plans.
- Managing the local clinical operations team by empowering and coaching them to deliver their key objectives.
- Third Party Monitoring- BA/BE Studies (US FDA, EMEA Studies)
- Third Party Auditor- Pharmacy Activities (Regulatory Submissions)
Site Management Officer - Meenakshi Mission Hospital - Madurai
(2012-07 - 2013-02)
- Oversee the critically important responsibility for establishing early lines of communication with the clinical teams as they are identified, selected and prepared for activation.
- Will be integral to propel accelerated timelines during the trial start-up cycle and then during subject accrual, assuring that monthly enrollment goals are met each month across all clinical sites.
- Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.
- Assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
- Oversee site compliance with investigational products, reporting or safety events and contracting.
- During trial implementation, oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.
- Conduct weekly (or more frequent) teleconferences and manage monthly training broadcasts with the clinical teams and individually mentor new coordinators and investigators.
- Responsible to keeping enrollments on track and clinical teams on schedule with established performance expectations.
- Provide support to quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.
- Responsible for managing site investigator relationships and executing site start up and performance plans, assigning tasks and deadlines to site clinical teams, directing and monitoring clinical site work efforts on a daily basis, identifying resource needs, performing quality reviews, and escalate functional, quality and timeline issues appropriately.
- Execute lean management processes and methodologies to ensure sites deliver on-time and within the budget, adhere to high quality standards, and benefit the investigative effort by ensuring smooth implementation of trial policies and goals from site launch through study activation and completion of the trial at the local levels.
- Will perform self-audits and audit performance of clinical sites; and the Site Manger will recommend changes to protocol operations based on audit results and revised goals.
- Responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with contracts personnel and IRB Navigators.
- Use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.
- Serve a critical role as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of study sites.
- Building and maintaining strong, trusting relationships is critical.
- Experience in representing trial policies and communicating scientific concepts to investigative teams, end-users (faculty and staff), and subject-matter experts; must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills, and exhibit a strong helpline orientation.
- Stay current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel.
- Serving as a knowledgeable liaison between the BIOS leadership and the research communities.
- Making independent judgments and to act on decisions on a daily basis, the ability to work for long periods of time without direction, and the ability to prioritize one's own work and work of others.
Study Manager - Micro Therapeutics Research Labs - Coimbatore
(2011-06 - 2012-06)
- Maintain and adhere to study project plans and timelines
- Train subcontracted resources, country study managers, nurses or other clinicians
- Provide support and guidance for subcontracted resources, including routine teleconferences to review progress to timelines, issue management, and information sharing
- Contact country study managers and/or clinicians to ensure visits are scheduled and have occurred per the required timelines
- Review study documentation to ensure completeness, accuracy and timeliness
- Seek or correct documentation, as needed
- Ensure CRM is updated, reports are reviewed and provided to the appropriate stakeholders timely and according to expected timelines
- Solicit information to support inquiries from all stakeholders
- Support all internal and external team members in their efforts to support the study
- Assist in training new team members
- Ensure Symphony is providing quality service
- Act as the liaison between the sponsor, CRO, investigative sites staff, laboratory, pharmacy and other internal and external personnel as the study requires
- Represent Symphony effectively and professionally in project calls, webinars, teleconferences and meetings
- Recognize sensitive issues and manage them effectively; escalate up when need assistance
- Comply with ICH/GCP, IATA, HIPAA and other appropriate regulations, policies and procedures
- Ensure that contracted study visits are completed on schedule, documentation is timely, complete and accurate and lab samples are evaluable
- Provide support and oversight for project financials and forecasting
- Perform other duties as assigned
Clinical Trial Research Intelligence - Point Perfect Transcription Services - Coimbatore
(2010-11 - 2011-05)
- Searching meeting availability
- Scanning the abstract availability
- Analyzing the in scope Clinical trials from the abstracts.
- Checking the Dupe identification which already present in (JeDI) Database software.
- Analyzing whether it is addition /Updation.
- Perform the action of the above conclusion.
- Review the records.
- Stamping the records and moved to In Production.
Clinical Research Associate - Quest Life Sciences Pvt Ltd - Chennai
(2009-05 - 2010-10)
- Responsible for setting up, coordinating and supervising clinical studies.
- Plan, prepare and help carry out clinical trials to test new or existing investigational products.
- The primary contact for various parties including doctors, researchers, laboratories, pharmacists, ethics committees and others such as the sponsor (usually a pharmaceutical company) or client.
- Carry out selection, initiation, monitoring and close-out visits at the participating clinical trial centres, also for logistics and coordination of the study;
- Monitor the study to check whether it has been carried out in accordance with applicable laws and regulations;
- Develop study procedures, methodology and instructions for clinical trials staff, as well as design data collection tools (case report forms);
- Manage study supplies, medication supplies and medication accountability;
- Collect, verify and finalize collected data to create reports and present results of findings to other medical staff;
- Ensure the safety and well-being of test subjects by liaising with ethics committees;
- Submission of clinical trial documents for review and approval by those ethics committees.
Business Executive - Bharat Biotech INT Limited - Hyderabad
(2008-09 - 2009-04)
- To procure prescriptions from the doctors.
- Observe competitors' activities and achieve monthly targets.
- Maintain product availability in the stockiest and pharmacy stores.
- To conduct scientific programs for physicians.
