Clinical Project Manager (Text version)
Manan K Trivedi
Address: 99111, Brussels, Belgium
Date of birth: 1999-19-09
Email address: email@example.com
Phone number: +999 999 999
- Clinical & Regulatory Project Management Professional over 9 years of rich industry experience on operational aspects of conducting clinical studies including vendor/CRO management, leading & working as collaborative clinical team, implementing clinical development plans and coordinating study level activities to deliver high quality data as per ICH-GCP, Client SOPs and protocol requirements (Phase II to III)
- Good exposure in regulatory product lifecycle maintenance activities of product renewals, variation filing, PSUR submission through liaising with different internal and external stakeholders to ensure quality submission readiness by time
- Extensive experience of end to end process of creation, set-up and maintenance activities of TMF & Document Management. Acting as SME and technology expert for eTMF inspection readiness for study teams by delivering various KPI reports to achieve compliance
- 2.5 years of line manager experience for assigning, directing work, appraising performance and guiding for professional development of team. Rewarding and disciplining team along with issue resolution and problem-solving sessions. coaching and mentoring team for project planning, review, risk management & problem-solving approaches to ensure global alignment of work practices through adoption and use or business processes, technology tools and continuous improvements
- Strong technological and functional expertise in various clinical and regulatory tools for project execution and management. Hands on experience on analytical tool like Spotfire through which delivered various important metrics and reports to senior management to empower them to make data driven decision making process and identifies key areas of improvements
- My academic program curriculum of MSc and PhD in Clinical Research enriched me in developing through understanding of principles and practice of scientific research, critical thinking abilities and analytical skills via many industry and group project assignments in different domains of clinical trials. My PhD research program provided me opportunity to work & critically analyze various PIII & PIV oncology trials data through systemic and meta-analysis
04/2018 - present, Regulatory Operations Consultant, GSK Vaccines through Experis, Brussels, Belgium
- Acting as primary support agent to the Regulatory Affairs department to enable the efficient delivery of core Regulatory Operations services to meet Global Regulatory Affairs (GRA) business objectives. Examples of such services include (but are not limited to) everyday electronic document management, Regulatory submission, pre-publishing, data intelligence for registration management & Regulatory planning and tracking activities.
- Also providing support to submission delivery team to ensure market specific requirements are met
- Responsible to support & consolidate the Regulatory Project Teams (RPT) Planning & Tracking for Project/Products under Responsibility
- Responsible for the Pre-Publishing (creation of the structure within the company’s electronic document management system (eDMS) and the sequence within the RIMS
- Responsible for making the link between LOCs (Local Operating Companies) & GIO (Global Industrialization Operations) for sharing Regulatory status & allowing QA Release & Supply Business continuity
- Provide ad hoc refresher training to GRA colleagues where users would benefit from learning more about how to effectively use the company’s tools and systems
- Provide advice and support regarding the technical aspects of electronic submission build and delivery: i.e. eCTD configuration / lifecycle management and conversion to other submission formats to maximize reuse.
10/2016 - 03/2018, TMF Project Manager, GSK Vaccines through Experis, Brussels, Belgium
- Acting as primary eTMF Business Process owner, setting and maintaining vision and road-map for eTMF compliant organization
- Acting as Business lead in special projects of eTMF viz. KPI and Metrics development (Through Spotfire), Data Migration strategy and process improvement
- Acting as interface between Sr Management, end-users and IT groups
- Responsible for leading quality practices, management monitoring, control document development, improvement and training related support
- Co-ordination with Head TMF Management, driving change and communication initiatives around TMF implementation, business intelligence and compliance
- Development and maintenance along with organizational change & continuous improvement for SOPs & Written Standards
- Managing TMF reference models & framework of Inspection readiness
- Engaged in different Stakeholder management activities
- Designing, analyzing and report data & Information trends to Senior Management
- Acting as a change agent by sharing latest advancements in GCP and regulatory requirements to different stakeholders
06/2014 - 10/2016, Clinical Project Manager, Freyr Regulatory Solutions, Hyderabad, India
- Responsible for the successful planning, implementation and execution of assigned clinical projects
- Oversee & manage clinical project development to ensure data quality and integrity
- Actively provide guidance & review of the scope of work, objectives, timelines, quality of deliverables, and other clinical project management activities for studies
- Assigning, and directing work; appraising performance & guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
- Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees
- Identifies unusual or significant risks encountered during the course of a clinical project and proposes strategies for preventing or correcting them
- Identify skill and competency gaps at the individual level and work to craft development plans that will close the gaps
- Working with individual staff to identify any quality issues within the study and coaching on resolution of issues, including implementation of corrective action plans and escalation
- Collaborate with other management and leadership team members to proactively identify project and or individual needs and resourcing solutions in order to manage study issues and obstacles
- Work with the client & Senior Management to ensure that project budget(s) meet financial and company goals (realization targets), with a focus on proactively ensuring adherence to change control processes
- Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans
- Reviews and assesses project profitability through the identification of “out of Scope” activity in a timely manner and supporting continuous process improvements
- Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison
09/2013 - 06/2014, TMF Owner, ICON Clinical Research, Chennai, India
- Working closely with functional team & PM to ensure deliverable with respect to SOPs, WIs & TMF plan
- Responsible to ensure that the clinical trial documentation Is Consistent with the Trial Master File Specifications, applicable SOPs, ICH-GCP guidelines and other regulatory agencies requirements
- Provide consistent setup & maintenance of TMF requirements, processes & programs
- Assist with internal & external audits with development of CAPA related to TMF findings
- Reviewing data quality outputs and audit outputs to identify trends per study and across programs with overall objective of TMF to be submission and inspection ready at all times
- Developing and assisting with implementation of TMF specification i.e. Regulatory packet requirements & mapping of TMF index with latest DIA RM periodically
01/2013 - 09/2013, Sr Regulatory Affairs Specialist, PPD, Mumbai, India
- Preparing & reviewing of regulatory submissions for Product Renewals, variations & PSURs through liaising with various internal and external clients in tracking & status update of project plans into submission tool
- Tracking of Product life cycle maintenance for a client
- Provide project specific regulatory technical expertise & co-ordination oversight for key client’s projects along with directing other GRAs assigned to support projects of responsibility
- Collaborate extensively with people throughout the company, with clients & with regulatory authorities
- Assist in identifying & recognizing out of scope activities in a contract in a timely manner & liaise with line manager to follow through all aspects of contract modification including project budgeting, forecasting & risk management
- Single point of contact for getting GMP and COPP certificate across the Globe
06/2010 - 01/2013, Study Start up & Regulatory Specialist, Syneos Health erstwhile INC Research, Gandhinagar, India
- Managing study startup & set-up activities from filling of documents, collection, review, submission, QC, archival & processing of essential documents to maintain up to date & complete TMF as per client, ICH-GCP and regulatory requirements
- Responsible for the preparation and coordination of submissions to ethics and other bodies
- Provide country specific Study Start Up expertise to Study Start Up Team Leads and project teams through effective oral & written communication among all project team with resolving and/ or transmitting messages of problems
- Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned
- Responsible for the collection of critical documents required for IP Release
- support PM for various tracking activities for site initiation and regulatory binder submission
- Provide support for identifying and mitigating risks & for internal and external audit along with generation of CAPAs
06/2009 - 06/2010, Clinical Research Associate, CARE Worldwide, Ahmedabad, India
- Ensuring appropriate development of study documents for CROs including but not limited to, informed consent forms, case report forms and instructions, site selection materials,IB updates and other project specific essential documents
- Planning & managing of all clinical study supplies to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, logs, supplies, equipment, and investigational product
- Providing training on project specific and GCP requirements for conduct of study to new staff of Study coordinator, Project team and investigator
- Motivate investigators for achieving patient recruitment targets & Complete accurate study status reports.
- Support development and review of ICFs, Protocol summary, IB & ensure its timely submission for ethics/IRB approval.
- Conduct and support Pre-study visits, Site initiation visits, and regular monitoring visits along with close out visit for sites
- Review and submit Monitoring visit reports into client system at appropriate timeline and follow up of outstanding issues
- Do IP accountability and reconciliation activity at site
- Perform source data verification at sites and ensure data is captured as per guideline, SOP and GCP requirements
- Involved in P2 and P3 trials of Gastrointestinal, Inflammatory and Infections diseases
09/2010 - 10/2015, PhD Clinical Research, Texila American University, Guyana
- TAU’s Extensive Research curriculum program of PhD. in Clinical Research allowed me to learn simultaneously in both the didactic course work and practical research areas of Clinical & Transnational Research.
- Biomedical-Patho-physiological Basis of Diseases, Pharmacology and Pharmacoeconomics, Drug discovery and development, Regulatory & Ethical Aspects of Clinical Trials. Clinical Data Management and Pharmacovigilance, Quality Control, Audit and Inspection in Clinical Trial, Medical writing / Reporting, PK, BA, BE in Clinical Trials, Molecular Biology and Biotechnology, Pharmaceutical Biotechnology, Computer Aided Drug Designing, SAS Programming & Epidemiology.
- Its extensive research program involved Systematic Literature review, Meta-data analysis projects, Data collection, Data mining, Text mining, Data Analysis, Data collation, Data Review, Critical appraisals, assignments & publication and presentation my research paper in International journal.
06/2007 - 05/2009, MSc Clinical Research, Cranfield University, Bedfordshire, UK
M.Sc. Program of Cranfield University allowed to attain & demonstrate my:
- Comprehensive understanding of the scientific requirements of drug discovery and clinical research in different settings (pharmaceuticals, devices, diagnostics, natural products, etc.).
- Apply ethical and regulatory principles appropriate to any research project.
- The knowledge of the reliability of medical evidence obtained through different approaches and to critically evaluate experimental designs and the appropriateness of their application.
- Interpret, critique and apply the information included in medical publications.
- Communicate both orally and in writing complex scientific data to a variety of audiences including the medical profession, regulatory authorities, media and patients.
- Ability to undertake an individual research project thus applying the principles of experimental design, data collection, analysis and critique.
04/2003 - 04/2007, B.Pharmacy, Saradar Patel University, Anand, India
10/2016, Spotfire Analyst, Tibco Spotfire
09/2016, Certified Lean Six Sigma Black Belt, Simplilearn
02/2016, Accredited Project Manager (APRM™), International Organization for Project Management
02/2016, Certified Six Sigma Black Belt (CSSBB), Ministry of Micro, Small & Medium Enterprises
03/2009, BASICs of SAS 9.0 & FDA Smart, ICRI India
05/2008, PGDCRM, ICRI India
Clinical Research Management
Working under pressure
Analytics - 90%
Project Management - 91%
Quality on Time - 80%
Process Improvement - 85%
Time Management - 75%
Proactive Thinking - 88%
- Invited as Speaker in International conference of eRegulatory Summit 2018, held at Lisbon, Portugal on Topic of Fully validated eTMF vs Hybrid (Pros and cons of both)
01/2014, LIFE (LOSARTAN INTERVENTION FOR END POINT REDUCTION) STUDIES IN HYPERTENSIVE PATIENTS IN REDUCING VARIOUS CV MORBIDITIES AND MORTALITIES INCLUDING STROKE vs. ATENOLOL, South American Journal of Clinical Research & International Journal of Health Sciences
Listening to Music
Playing chess, Volley ball & Cricket
Technology & Smartphone enthusiast
Learning new things
05/2010 - present, Swayamsevak, BAPS, Antwerp, Globally
It is enlighten feeling to serve people and help others. Proud to be in BAPS.