Ma. Celeste Mandal

1 |Page CURRICULUM VITAE ____________________________________________________________________________ PERSONAL DETAILS: Full Name: Ma. Celeste Mandal Location: Philippines Mobile No: - Home No.: - Email address:- BIOGRAPHY: 11 years’ experience with Pharma and CRO, in a variety of line management and technical roles, working across wide variety of therapeutic areas in the Philippines. Development, implementation and maintenance of country operational processes geared towards efficiency, consistency and quality compliance. Drive and own strategies for non-project issues such as site business strategy, infrastructure and capabilities, mutual recruitment pipelines, achieving patient recruitment and performance results. Extensive Quality and Compliance function roles performed including Quality and Compliance visits (Accompanied site visits), study site risk assessment and identification, development of Quality and Compliance Plan and Quality and Compliance report. Line management of clinical research associates with mentoring and coaching responsibilities and training facilitation, being an advocate of individual development plan. Depth of experience working cross-functionally and cross-culturally in local and regional roles across all levels of the organisation. I fosters a quality mind-set within my teams and has a high work ethic. I commenced a position as Clinical Research Associate (CRA) I with Janssen in 2005, responsible for the initiation, monitoring and closing out of studies with contracted scope and ICH-GCP. Took on the same responsibility with Quintiles and progressed to CRA II then moved to I3 and Covance. In 2011, took on a Global Site Services Specialist II role where I joined the study start up team, focusing on project start-up activities. Having proven abilities and technical skills in site and quality management, I took the role of Clinical Trial Lead in Clintec for Boehringer Ingelheim account, with main responsibility of risk assessment of site and monitoring performance, and supporting audit and inspection activities. In 2014, I joined back Quintiles and has performed several functions started with Clinical Research Specialist then forwarded my career to Associate Manager mainly focused on Regulatory Start-up where I made significant contribution to the improvement of the company’s regulatory processes and operations. Throughout my progression, I was recognized for my leadership and managing quality processes. In 2016, I took on the role as Site Network Manager, where I was responsible for site business strategy, infrastructure and capabilities, mutual recruitment pipelines, achieving patient recruitment, performance results for assigned sites, quality Ma. Celeste S. Mandal CV Version Date: February 2018 2 |Page monitoring, investigator site assessment, and selection and training of new CRAs. In 2017, my career progressed to Associate Manager for Site and Resource, I had the opportunity to support strategies and action plans to maximize delivery of a high-quality team/department monitoring service, ensuring achievement of individual/team/department targets, aligning with company strategies. In these roles, I have prepared and managed CAPAs, and was responsible for providing follow-up until closure. My passion for quality across all aspects of the business is evident in the way I strives to improve processes and lead cross-functional teams. I completed a Bachelor of Science in Respiratory Therapy at St. Jude University, Manila in 1999 and attended Masters in International Clinical Research and Technology in Edinburgh Napier University, UK in 2014. THERAPEUTIC AREAS: Auto-Immune Cardiovascular Endocrinology Gastrointestinal Hematology Neurology Oncology Pulmonary Women's Health EMPLOYMENT: Date Job Title Company/Location April 2017 – Dec. 2017 Associate, Site and Resource IQVIA (Quintiles) Manager Philippines Main activities/responsibilities: • Support the formulation of strategies and action plans to maximize delivery of a high quality team/department monitoring service, ensuring achievement of individual/team/department targets, aligning with company strategies. Ma. Celeste S. Mandal CV Version Date: February 2018 3 |Page • With support, ensure sufficient level and profile of resource is recruited for each project. Maintain systems compliance and oversight for effective project delivery. Collaborate with the Clinical Lead/Project Lead to ensure that resource needs and site requirements are met. • Manage key strategic site relationships in order to build capability, drive productivity and robust quality management in line with site strategy. Be an advocate for these sites within Quintiles. • Manage, develop, coach, and motivate CRAs to develop their skills to ensure that a high professional standard is achieved and project targets are met. Be an advocate for individual career development. • Conduct Accompanied Site Visits (ASV’s) to develop CRA’s skills (e.g. patient recruitment). Support CRA’s on solving project specific issues across site portfolio. • Identify quality risks and issues and suggest appropriate corrective action plans to senior management to prevent or correct deficiencies in performance of employees. • Share Quintiles and customer key business drivers with all CRA staff. Drive decision making in line with these. • Attend customer meetings, maintain interactions with any local sponsor affiliates. • Support maximization of profitability by ensuring project objectives and customer requirements are achieved • Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan and mentored training experiences. • Ensure timely and accurate reporting of required information on company systems. • Support continuous improvement of monitoring processes to deliver quality, consistency and efficiency in delivery. • Participate in the selection process for new staff by conducting candidate review and participating in the interviewing process. Conduct on-boarding training for new staff in conjunction with Human Resources and Learning and Development training programs. • Project a professional impression of the Company and act in accordance with the relevant Pharmaceutical Industry’s Code of Practice • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; gathering feedback for appraising performance, guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters in consultation with Human Resources and other relevant departments. • Establishes and maintains relationship with key opinion leaders, regulatory authorities and government organizations involved in new drug development to identify and develop a pool of reliable / potential investigators and investigation sites as well as to be up-to-date with the latest local regulations and practices • Conduct trainings for specific therapeutic areas such as SLE, DM and Oncology and conducts training on ICH-GCP, local regulatory and company policies. • Supports and conducts workshops for root cause analysis and CAPA as part of Quintiles quality initiative Ma. Celeste S. Mandal CV Version Date: February 2018 4 |Page on a yearly basis. • Performs risk assessments of studies and creates Quality and Compliance plan accordingly. • Acts as Local country assessor as part of CRA recognition program for Audit and Inspection readiness. • Conducts Quality and Compliance Visits to ensure clinical trial sites are audit and inspection ready. • Prepares risk assessment of quality visits and support the Clinical Lead/Project Lead in coming up with corrective and preventive action plans. • Prepares project specific Quality and Compliance Report to reflect the outcome of quality and compliance visits as well as relevant activities in the country that would impact quality and compliance (i.e. audits, inspections, trainings, issues, etc) and Communicates/escalates quality/compliance issues including potential quality issues to local country operations management • On a monthly basis and in collaboration with local country operations, identifies local trends, performs rootcause-analysis (if necessary) and develops local action plan. Results and agreed plans are shared and included in the training of local country operations team. • Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection. – Involve in various audits; Performing mock interviews with CRA’s/site to prepare for the Audit. • Develop corrective and preventive action plans and perform root cause analysis in response to audit observations. • Lead and support key initiatives and process improvements in accordance to Quintiles processes. Jan. 2016 – April 2017 Site Network Manager IQVIA (Quintiles) Philippines Main activities/responsibilities: • Ensure right sites are selected for assigned studies by collaborating with project strategy and project teams • Focus and concentrate more projects into fewer sites through improved capabilities for enhanced recruitment performance • Own and optimize project delivery across portfolio of sites including linkage to the therapeutic requirements of the future (productivity, quality, thought expertise) • Assist in driving and owning strategies for non-project issues such as site business strategy, infrastructure and capabilities, mutual recruitment pipelines, achieving patient recruitment and performance results for assigned sites • Conduct Accompanied Site Visits (ASVs) to guide CRAs and advise on critical specific study issues • Support CRAs on resolving project specific issues across site portfolio • Support process improvement through working with Quintiles processes to deliver quality and consistency in assigned geographic territory Ma. Celeste S. Mandal CV Version Date: February 2018 5 |Page • Evaluate, develop and regional site portfolio through regular on-site visits • Mentor CRAs guiding professional development across assigned mentees • Assist in the selection and onboarding process for new CRA's by conducting candidate review and participating in the interviewing process • Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Sept. 2015 – Jan. 2016 Associate Manager IQVIA (Quintiles) (Regulatory Start Up) Philippines Main activities/responsibilities: • Accountable for the oversight and execution of Start Up (from pre-award up to Maintenance and Investigational Product (IP) release for all assigned projects in accordance with the agreed RSU strategy • Local expert for ICH-GCP and local regulations. Working closely with regulatory Manager and Quality Manager for impact assessments of new and updated local regulations on local processes. • Working closely with Regulatory Manager and Quality Manager for impact assessments of new and updated local regulations on local processes • Responsible for the development, maintenance and implementation of the RSU plan according to the Scope of Work and Project Plan within the agreed strategy, escalating issues where required • Ensure cross collaboration across RSU and communication with regions and countries to successfully implement the agreed RSU plan • Provide overall guidance and oversight of multi-site projects during maintenance phase as an integral member of the study management team • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents • Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan • Assess and review regulatory landscape and contribute to collection, interpretation, analysis and dissemination of accurate regulatory intelligence • Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required • Work with Quality Management to ensure appropriate quality standards for the duration of the startup Ma. Celeste S. Mandal CV Version Date: February 2018 6 |Page • Mentor and coach colleagues as required and provide technical guidance both within and outside the project • Ensure accurate completion of relevant Clinical Trial Management System (CTMS) fields in accordance with role Oct. 2014 – Dec. 2015 Clinical Research Specialist IQVIA (Quintiles) Philippines Main activities/responsibilities: • Guide and direct the work of CRAs on site, providing mentoring to ensure quality deliverables of assigned CRAs • Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per Contract • Will conduct site monitoring visits for a variety of protocols, sites and therapeutic areas as needed • Provide input, updates to the Clinical Project Manager regarding the monitoring status and CRA team progress and deliverables • Act as subject matter expert for operational conduct of the assigned protocol(s) at site • Ensure that new project CRAs are brought on board and receive relevant study information • Provide input to line managers on their project team members’ performance relative to study tasks • Conduct co-monitoring visits to manage data backlog, site compliance and quality issues, may be beyond home geography • May act as site visit report reviewer for assigned studies • May take on special project assignments related to function/corporate initiatives June 2014 – Sept. 2014 Clinical Trial Lead Clintec International (Working under assignment for Boehringer Ingelheim) Main activities/responsibilities: • Performed co-monitoring visits as delegated by Regional Project Manager (RPM) to determine if the trial conduct and clinical monitoring done by CRA/Clinical Research Organization (CRO) is in compliance with the protocol, Standard Operating Procedures (SOPs), ICH-GCP and all applicable regulations to ensure that the rights and well-being of the patients are protected and that the study data are accurate and reliable • Reviewed site selection visit, site initiation visit, on-site monitoring visit and close-out visit reports completed by CRO • Identify issues from the review and provide to RPM or CRO, as delegated by RPM, for follow up Ma. Celeste S. Mandal CV Version Date: February 2018 7 |Page • Reviewed the Clinical Trial Master File (CTMF) on a regular and ad-hoc interval to ensure all essential documents are in the appropriate files and identify any deficiencies in the documentation before study start, during study conduct and at study close-out to ensure protocol, SOPs and regulatory compliance • Assisted the RPM in the relevant activities and tasks in relation to audits and inspection preparation as well as logistic including in the review and response to audit/inspection queries as well as any audit/inspection reports • Followed-up on co-monitoring visit/site visit report review/CTMF review/audit/inspection issues as well as corrective action and preventive action (CAPA) with CRA or CRO, if delegated by RPM April 2012 – May 2014 Senior Clinical Research Clintec International Associate Main activities/responsibilities: • Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice • Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas • Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues • Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM) and/or line manager • Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution • Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation • Acted as a mentor for clinical staff including conducting co-monitoring and training visits • Provided assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes June 2011 – April 2012 Global Site Services Specialist II Covance Philippines Main activities/responsibilities: • Developed project specific plans for the GSS component of assigned studies • Liaised with operational project team regarding project issues (i.e., participate in team meetings) Ma. Celeste S. Mandal CV Version Date: February 2018 8 |Page • Collected, reviewed and approved process and tracked regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan • Reviewed and approved core English patient informed consents for compliance to international requirements and protocol as applicable • Reviewed and approved core Country patient informed consents for compliance to country requirements and protocol as applicable • Reviewed and approved investigative site specific patient informed consents for required elements • Resolved informed consent and contractual language issues by exercising advanced judgment when interacting with study sites • Negotiated contracts and budgets with investigative sites within parameters provided by Sponsor • Liaised with Sponsor and Covance regulatory regarding document submission requirements • Maintained and updated document tracking, site address and contact information in the Site Information module • Assessed impact of changes in study personnel and document amendments on regulatory documents (including Informed Consent) and process/review/approve new documents according to GCP/ICH guidelines • Assessed impact of study amendments on Informed Consent and other study documents and revise and review/approve accordingly • Prepared new investigator submission packages to Local and/to Central IRB/IEC • Attended ongoing training in GCP, project specific requirements and as may generally be required • Provided milestone information for incorporation into weekly analysis sheets • Monitored performance of GSS team with regard to project timelines • Performed administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying) • Managed set up and maintenance of investigative site files • Understood and followed project specific and GSS policies and procedures • Managed the drug supply vendor activities as applicable • Developed, reviewed and approved drug supply labels as applicable • Independently researched and evaluated proposal request from clients in all therapeutic areas within agreed timeframes • Assumed responsibility for the preparation and dissemination of documents according to the feasibility processes in place • Created surveys to probe “thought leaders” and experienced researchers and clinicians in the field for expert feedback Ma. Celeste S. Mandal CV Version Date: February 2018 9 |Page Feb. 2009 – May 2011 Clinical Research Associate II Covance Philippines Sept. 2008 – Feb. 2009 Clinical Research Associate II I3 Philippines July 2007 – Sept. 2008 Clinical Research Associate II Quintiles Philippines June 2006 – June 2007 Clinical Research Associate I Quintiles Philippines May 2005 – May 2006 Clinical Research Associate I JANSSEN (Johnson & Johnson) Philippines Inc. Main activities/responsibilities: - Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. - Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas. - Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM) and/or line manager. - Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. - Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letter and other required study documentation. - Provided assistance to less experienced clinical staff. LANGUAGES: Languages Level of Fluency Tagalog-Filipino-Pilipino Native English Fluent Ma. Celeste S. Mandal CV Version Date: February 2018 10 | P a g e EDUCATION: Year of completion Qualification Institution 2014 Masters - International Clinical Edinburgh Napier Research and Technology University, United (did not complete) Kingdom Bachelor of Science St. Jude College, 1999 Manila, Philippines I.T. SKILLS: MS Word, Excel, PowerPoint and Outlook CERTIFICATIONS: Expert GCP Training- Barnett Educational Services, 2015 Expert GCP Training- Barnett Educational Services, 2016 CLINICAL TRIAL EXPERIENCE • Participated in the 1st Philippine inspection conducted by the Philippine Food and Drug Agency • Managed and monitored quality and compliance of research and development (R&D) studies being conducted in the Philippines • Participated in the identification of potential investigators, contacts and visits, initiation of sites for participation in clinical trials, as well as in the evaluation, planning, and implementation of clinical trial protocols • Monitored at investigator’s sites and ensured adequacy of clinical research staff and facilities according to Sponsors' Standard Operating Procedures (SOP) and/or client guidelines in adherence to Good Clinical Practices (GCP) and International Regulatory requirements Coordinated the translation of applicable study documents • Performed start-up activities such as site selection visit, budget negotiation with investigators, and assisted in the preparation of Investigator’s meeting and trainings • Attended seminar and training programs corresponding to the project • Local expert for ICH-GCP and local regulations. Ma. Celeste S. Mandal CV Version Date: February 2018