Clinical Project Manager

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Clinical Project Manager (Full Text Version)

Manan K Trivedi

Address: 99111, Brussels, Belgium
Nationality: Indian
Date of birth: 1999-19-09
Email address: hello@kikcresume.com
Phone number: +999 999 999
Web: kickresume.com

Profile summary

Experienced Clinical & Regulatory Project Management Professional with over 9 years of industry expertise in overseeing operational aspects of clinical studies. Skilled in managing vendors/CROs, leading clinical teams, implementing development plans, and coordinating study activities to ensure high-quality data in compliance with ICH-GCP, Client SOPs, and protocol requirements (Phase II to III). Proven track record in regulatory product lifecycle maintenance, including product renewals, variation filing, and PSUR submission by collaborating with internal and external stakeholders to ensure timely and quality submissions. Demonstrated proficiency in creating, setting up, and maintaining TMF & Document Management processes. Serves as a subject matter expert and technology specialist for eTMF inspection readiness, delivering KPI reports to ensure compliance. Experienced line manager with 2.5 years of experience in directing team tasks, performance appraisals, and professional development. Skilled in issue resolution, coaching, and mentoring for project planning, risk management, and problem-solving approaches to align global work practices and drive continuous improvements. Technologically adept in clinical and regulatory tools for project execution and management. Proficient in analytical tools like Spotfire, providing crucial metrics and reports for senior management decision-making and identifying areas for improvement. Academic background includes an MSc and PhD in Clinical Research, enhancing skills in scientific research, critical thinking, and analytical abilities through industry and group project assignments. Conducted critical analysis of PIII & PIV oncology trial data through systemic and meta-analysis during PhD research program.

Work experience

04/2018 - present, Regulatory Operations Consultant, GSK Vaccines through Experis, Brussels, Belgium
  • Supported Regulatory Affairs department in delivering core services to meet Global Regulatory Affairs business objectives, including electronic document management, Regulatory submission, pre-publishing, data intelligence, and tracking activities.
  • Assisted submission delivery team in meeting market-specific requirements.
  • Supported and consolidated Regulatory Project Teams' Planning and Tracking for assigned projects/products.
  • Managed Pre-Publishing activities within the company’s electronic document management system and the Regulatory Information Management System.
  • Facilitated communication between Local Operating Companies and Global Industrialization Operations to ensure Regulatory status sharing and business continuity.
  • Conducted ad hoc refresher training for colleagues on utilizing company tools and systems effectively.
  • Provided technical advice and support for electronic submission build and delivery, including eCTD configuration, lifecycle management, and conversion to maximize reuse.
10/2016 - 03/2018, TMF Project Manager, GSK Vaccines through Experis, Brussels, Belgium
  • Spearheaded eTMF Business Process ownership, establishing and maintaining the vision and roadmap for a compliant organization.
  • Led special projects in eTMF, including KPI and Metrics development through Spotfire, Data Migration strategy, and process improvement.
  • Served as the key interface between Senior Management, end-users, and IT groups.
  • Directed quality practices, management monitoring, control document development, improvement, and training support.
  • Coordinated with Head TMF Management to drive change and communication initiatives for TMF implementation, business intelligence, and compliance.
  • Developed and maintained SOPs and Written Standards, focusing on organizational change and continuous improvement.
  • Managed TMF reference models and frameworks for Inspection readiness.
  • Led various Stakeholder management activities.
  • Designed, analyzed, and reported data and information trends to Senior Management.
  • Acted as a change agent by sharing the latest advancements in GCP and regulatory requirements with stakeholders.
06/2014 - 10/2016, Clinical Project Manager, Freyr Regulatory Solutions, Hyderabad, India
  • Successfully planned, implemented, and executed assigned clinical projects
  • Oversaw and managed clinical project development to ensure data quality and integrity
  • Provided guidance and reviewed scope of work, objectives, timelines, and quality of deliverables for studies
  • Assigned and directed work, appraised performance, guided professional development, and addressed employee relations issues
  • Coached and mentored employees on project planning, review, risk management, and problem-solving
  • Identified and proposed strategies to prevent or correct unusual or significant risks in clinical projects
  • Identified skill and competency gaps at individual level and crafted development plans to close them
  • Collaborated with management to proactively identify project and individual needs and resourcing solutions
  • Ensured project budgets met financial goals and adherence to change control processes
  • Facilitated hand-off and kick-off meetings to identify risks and develop contingency plans
  • Reviewed project profitability and supported continuous process improvements
  • Participated in corporate initiatives, special projects, and served as client liaison or cross-functional liaison within department.
09/2013 - 06/2014, TMF Owner, ICON Clinical Research, Chennai, India
  • Collaborated closely with functional team and Project Manager to ensure deliverables in accordance with SOPs, WIs, and TMF plan.
  • Ensured clinical trial documentation consistency with Trial Master File Specifications, SOPs, ICH-GCP guidelines, and regulatory agencies requirements.
  • Provided consistent setup and maintenance of TMF requirements, processes, and programs.
  • Assisted with internal and external audits, developing CAPA related to TMF findings.
  • Reviewed data quality outputs and audit outputs to identify trends per study and across programs, with the overall objective of TMF being submission and inspection ready at all times.
  • Developed and assisted with the implementation of TMF specifications, including Regulatory packet requirements and mapping of TMF index with latest DIA RM periodically.
01/2013 - 09/2013, Sr Regulatory Affairs Specialist, PPD, Mumbai, India
  • Prepared and reviewed regulatory submissions for Product Renewals, variations, and PSURs by liaising with internal and external clients, tracking project plans, and providing status updates in submission tool.
  • Tracked Product life cycle maintenance for a client.
  • Provided project-specific regulatory technical expertise and coordination oversight for key client projects, directing other GRAs as needed.
  • Collaborated extensively with stakeholders within the company, clients, and regulatory authorities.
  • Assisted in identifying and addressing out-of-scope activities in contracts, liaising with line manager to manage contract modifications including project budgeting, forecasting, and risk management.
  • Served as the single point of contact for obtaining GMP and COPP certificates globally.
06/2010 - 01/2013, Study Start up & Regulatory Specialist, Syneos Health erstwhile INC Research, Gandhinagar, India
  • Managed study startup & set-up activities, including 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.
  • Prepared and coordinated submissions to ethics and other bodies.
  • Provided 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.
  • Conducted feasibility, site identification, site contract negotiation, and other study start up activities, as assigned.
  • Collected critical documents required for IP Release.
  • Supported PM for various tracking activities for site initiation and regulatory binder submission.
  • Provided 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
  • Developed study documents for CROs, including informed consent forms, case report forms, site selection materials, IB updates, and other essential project-specific documents
  • Planned and managed all clinical study supplies to support the execution of clinical projects, including distribution of documents, forms, logs, supplies, equipment, and investigational products
  • Provided training on project-specific and GCP requirements to new staff including Study Coordinators, Project Team members, and Investigators
  • Motivated investigators to achieve patient recruitment targets and completed accurate study status reports
  • Supported the development and review of ICFs, Protocol summaries, and IBs, ensuring timely submission for ethics/IRB approval
  • Conducted and supported Pre-study visits, Site initiation visits, regular monitoring visits, and close-out visits for sites
  • Reviewed and submitted Monitoring visit reports into the client system within appropriate timelines and followed up on outstanding issues
  • Conducted IP accountability and reconciliation activities at sites
  • Performed source data verification at sites to ensure data capture in accordance with guidelines, SOPs, and GCP requirements
  • Participated in P2 and P3 trials for Gastrointestinal, Inflammatory, and Infectious diseases.

Education

09/2010 - 10/2015, PhD Clinical Research, Texila American University, Guyana
  • Engaged in TAU’s Extensive Research curriculum program for PhD in Clinical Research, acquiring knowledge in didactic coursework and practical research areas of Clinical & Transnational Research.
  • Studied Biomedical-Patho-physiological Basis of Diseases, Pharmacology, Drug discovery and development, Regulatory & Ethical Aspects of Clinical Trials, Clinical Data Management, Pharmacovigilance, Quality Control, Audit and Inspection in Clinical Trial, Medical writing/Reporting, PK, BA, BE in Clinical Trials, Molecular Biology, Biotechnology, Pharmaceutical Biotechnology, Computer Aided Drug Designing, SAS Programming & Epidemiology.
  • Participated in Systematic Literature review, Meta-data analysis projects, Data collection, Data mining, Text mining, Data Analysis, Data collation, Data Review, Critical appraisals, assignments, and publication and presentation of research paper in an International journal.
06/2007 - 05/2009, MSc Clinical Research, Cranfield University, Bedfordshire, UK
  • Acquired a comprehensive understanding of the scientific requirements of drug discovery and clinical research in various settings (pharmaceuticals, devices, diagnostics, natural products, etc.).
  • Applied ethical and regulatory principles to all research projects.
  • Demonstrated knowledge of the reliability of medical evidence obtained through various approaches and critically evaluated experimental designs.
  • Interpreted, critiqued, and applied information from medical publications.
  • Effectively communicated complex scientific data orally and in writing to diverse audiences, including the medical profession, regulatory authorities, media, and patients.
  • Successfully undertook an individual research project by applying principles of experimental design, data collection, analysis, and critique.
04/2003 - 04/2007, B.Pharmacy, Saradar Patel University, Anand, India

Skills

Languages
English
Hindi
Gujarati
Technical
MS Office
Project Planning
MS Project

Certificates

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

Strengths

Ambitious
Leadership
Business storytelling
Confident
Creativity
Dedication
Decision making
Collaborating effectively
Motivated
Working under pressure
Pro-active
Time Management
Future focus
Critical thinking
Public speaking
Strategic thinking

Core Strengths

Analytics - 90%
Project Management - 91%
Quality on Time - 80%
Process Improvement - 85%
Time Management - 75%
Proactive Thinking - 88%

Achievements

  • 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)

Publications

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

Hobbies

Travelling
Photography
Listening to Music
Playing chess, Volley ball & Cricket
Technology & Smartphone enthusiast
Learning new things

Volunteering

05/2010 - present, Swayamsevak, BAPS, Antwerp, Globally
  • Dedicated volunteer at BAPS organization, providing compassionate service to those in need.
  • Passionate about making a positive impact in the community through volunteer work.
  • Committed to supporting and assisting individuals in various capacities.
  • Honored to be part of such a reputable and impactful organization like BAPS.

Milan’s work-life has been centered around job search for the past three years. He is a Certified Professional Résumé Writer (CPRW™) as well as an active member of the Professional Association of Résumé Writers & Careers Coaches (PARWCC™). Milan holds a record for creating the most career document samples for our help center – until today, he has written more than 500 resumes and cover letters for positions across various industries. On top of that, Milan has completed studies at multiple well-known institutions, including Harvard University, University of Glasgow, and Frankfurt School of Finance and Management.

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