Manli Chen

Manli Chen Email and Phone Number

Energetic, high-performing, solution-oriented, resourceful, and result-driven Senior Clinical Trial Manager with effective and inspiring leadership skills @ Gilead Sciences
Manli Chen's Location
San Francisco Bay Area, United States, United States
Manli Chen's Contact Details
About Manli Chen

Performance Summary: Global Business Insights and Leadership // Cross-functional Project Management // Research and Analytic Expertise // System Optimization & Integration // Localization✓ Global Clinical Research Expertise: Highly motivated clinical study program lead with 13 years of critical operational experience on a global scale supporting Phase 2 to Phase 4 clinical studies from startup to closeout, and strategizing patient recruitment campaigns; proven ability in balancing multiple complex drug development projects and executing overall trial plans robustly and efficiently ensuring FDA, EMA, and ICH compliance. ✓ Cross-functional Leadership: Solution-driven Clinical Trial Manager with proven record of effective collaboration with clinical and scientific staff and global internal/external study partners resulting in optimal clinical trial delivery.✓ International Vendor and Alliance Partner Management: Dynamic and adaptive partner/vendor specialist and relationship manager with in-depth experience working effectively with alliance partners and business vendors in Asia, Europe, and Africa, successfully fostering trusted and mutually beneficial relationships across multiple stakeholder groups.✓ Effective Communication: Engaging and multilingual communicator in English, Mandarin, Cantonese, and Shanghainese with valuable cultural insights and pragmatic approach to localization; excels in presenting compelling, in-depth research findings and project solutions to executives and international audiences.✓ Strong Analytical Performance: Data-driven MBA with extensive experience collecting and analyzing clinical trial data, developing valuable insights, and presenting actionable and compelling findings to executives and international audiences at global conferences. o “Values at Work” award for “extraordinary efforts in support of COVID-19 crisis response and development of Remdesivir”.o “Values at Work” award for “demonstrating Gilead’s core values in the way you approach your work” in leading the resolution of major clinical supply issues and establishing comprehensive and effective work processes.o “Values at Work” award for “leadership and support as the Communications and Marketing Lead of the GAIN ERG”.o “Departmental Star” award for “leadership in driving and resolving many complex issues”. o “G. Thanks” award for “moderating the first GAIN Book Club discussion with dedication”.

Manli Chen's Current Company Details
Gilead Sciences

Gilead Sciences

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Energetic, high-performing, solution-oriented, resourceful, and result-driven Senior Clinical Trial Manager with effective and inspiring leadership skills
Website:
gilead.com
Manli Chen Work Experience Details
  • Gilead Sciences
    Senior Clinical Trial Manager, Development Operations, Clinical Operations In Oncology
    Gilead Sciences Apr 2024 - Present
    Foster City, Ca, Us
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  • Gilead Sciences
    Senior Clinical Trial Manager, Development Operations, Lp Clinical Operations
    Gilead Sciences Sep 2021 - Apr 2024
    Foster City, Ca, Us
    o Efficiently spearhead global Gilead sponsored Hepcludex study (11-country, 85 sites, 850 pts) to gain accelerated FDA approval by expediting study startup and CRO onboarding process to shorten study timeline, strategizing effective country-level rollout plans to achieve aggressive response time to FDA, and launching site selection and feasibility effectively with significant CRO cost savings. o Drive Gilead sponsored Purpose 1 and 2 (lenacapavir) as Trial Lead to collect valuable qualitative insights and clinical data to support successful FDA filing, approval, and commercial launch by ensuring clear objectives and directions for all external collaborators and internal stakeholders in G.Ecosystem and adjusting strategies and tactics throughout the program. o Successfully lead program/SOP development and strategic formulation for Gilead’s first Intermediate-size Population Expanded Access Program (ISP-EAP) for oncology TA and guide Named Patient Compassionate Use expansion into EU27 and ACE regions (Team award: 2023 Global Innovation Forum Finalist). o Efficiently manage early phase oncology trial to ensure challenging issues being resolved promptly through thorough investigation of root causes, strong collaboration and partnerships with key stakeholders and CRO/vendors, clear and timely communications, and resourceful/adaptive approach. o Recognized as a Subject Matter Expert and successfully contributed to the satisfactory pass of 2024 FDA Inspection. o Strategize responses to FDA’s inquiries for oncology trials. o Effectively manage CRO/vendor teams and collaborate with cross-functional leads to develop online request portal specs and incorporate regulatory insights to establish 5 comprehensive online portals to streamline processing of increased number of global requests.o Efficiently resolve CRO, HCP, regulatory, and logistics challenges to ensure timely drug supplies to critically ill global cancer patients.o Nominated for 2023 “Career Mentor Star”.
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  • Gilead Sciences
    Clinical Trials Manager, Development Operations, Lp Clinical Operations
    Gilead Sciences Sep 2018 - Sep 2021
    Foster City, Ca, Us
    o Drive operational success and strategies of cross-TA Gilead-sponsored (GS) clinical studies and 35+ investigator-sponsored and collaborative studies, ensuring all aspects of clinical trials are conducted within planned timelines and budgets. o Partner closely with CPMs and functional heads to lead collaboration across disciplines ensuring efficient execution of clinical trials, database infrastructure build, data listing review, and timely completion of interim and final CSRs to successfully meet regulatory requirements. o Manage SMT meetings and cross-functional Operations Tracking Meetings with ongoing guidance and oversight of project statuses to proactively identify operational challenges and provide risk mitigation solutions. o Lead cross-functional teams’ initiative to resolve challenging clinical supply issues through establishing strong relationships with key stakeholders and senior vendor leads, accurately identifying root causes, and proposing effective solutions, resulting in a streamlined process that ensures successful clinical supply support for 15 clinical studies with financial impact of $1.5 million. o Train CROs, vendors, study investigators, and staff on GS study requirements. o Active in vendor selection process, RFP review, and contracting negotiation, closely collaborating with vendor outsourcing team (e.g., led vendor negotiation to reduce overall study logistic support costs by 50% for studies across HIV and liver TAs). o Effectively manage CRO vendors and clinical data vendors, ensuring Gilead’s study expectations and timeline. o Communications and Marketing Lead at GAIN (2019 – 2022): Drive GAIN messaging efforts on multiple platforms and play key role in developing a series of online learning seminars and programs for 800+ members. o Lead various departmental team-building events, volunteering service programs, and participate in CTM forum planning and implementation committee.
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  • Ppd
    Senior Clinical Project Manager, Clinical Study Project Management
    Ppd May 2016 - Jan 2018
    Wilmington, Nc, Us
    - Achieved 23% project cost reduction by leading a challenging 15-country global study, making timely strategic adjustments, partnering closely with cross-functional team leads and clinical sites, tactically implementing mitigation steps, and aligning milestone goals among sub-teams with the overall clinical study goal.- Executed the full life cycle of 6 global clinical study enrollment projects, with proactive involvement in clinical strategy, project planning and implementation, investigator/kick-off meetings, clinical site/vendor selection and contracting, data collection and analysis, performance reporting and presentations, budget management and forecasting, to exceed performance goals and consistently deliver timely and quality trial results.- Conducted 10+ global training seminars and educational webinars to ensure key stakeholders’ (e.g., sponsors, CROs, and investigative sites) compliance with FDA/EMA regulations and ICH/GCP guidelines when conducting clinical trial data collection and validation, recruitment performance tracking, and final reporting.- Achieved 20% project management time-saving among PMs by devising process standardization and consolidations for senior leadership and acquiring team leads’ endorsement and implementation, resulting in enhanced operational effectiveness and optimal company profits.
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  • Bbk Worldwide
    Senior Global Project Consultant
    Bbk Worldwide Jul 2015 - Apr 2016
    I worked as the Senior Data Integration Manager for BBK Worldwide full-time through July 2015 due to family relocation to Silicon Valley and continue to work as a remote senior project consultant on a project basis.
  • Bbk Worldwide
    Senior Global Data Integration Manager
    Bbk Worldwide Sep 2011 - Jul 2015
    - Managed global clinical trial projects of various phases in a deadline driven, fast-paced environment, collaborating with study sponsors and/or CROs to determine protocol requirements, key performance indicators, project milestones and critical paths, reviewing solutions for potential challenges, and building solid IT infrastructure to ensure efficient project deployment and completion on time and within budget. - Achieved global trial success by developing effective trial plans, executing metric-based clinical site/SP selections and RFPs, ensuring key stakeholders’ (e.g., sponsors, CROs, investigative sites, and data processing team) compliance with ICH guidelines and FDA regulations when conducting clinical trial data collection, validation and import, conducting regular recruitment performance tracking, deploying clinical trial management best practices, and providing responsive trial consultation, technical support, and training seminars. - Successfully collaborated with various third party vendors to implement clinical system integration and to innovate clinical trial productivity enhancement products including global trial reimbursement programs, multi-country SMS trial visit reminder services, trial participant engagement mobile applications, and clinical study e-binders. - Significantly increased global user adoption of cloud-based clinical data management system from international user base by hosting worldwide training and educational webinars, conducting user research and system performance evaluation to enhance feature quality, and providing responsive technical and admin assistance to end users from 30+ countries. - Strengthened business relationships with Fortune 100 clients to achieve high retention rates and follow-on project awards, and expanded new client base by analyzing target market dynamics, identifying future trends in demand and unmet client needs in various global markets, generating effective marketing strategies.
  • Bbk Worldwide
    Global Clinical Project Manager / Strategic Alliance Partner & Vendor Management Specialist
    Bbk Worldwide Jul 2009 - Aug 2011
    - Reached project goals three months ahead of allotted timeline by efficiently managing multi-country project critical paths, launching effective multi-channel marketing campaigns using marketing automation tool, navigating ambiguity with sound judgment, and making decisive strategic adjustments based on real-time data analysis and situational evaluation. - Managed large-scale international projects overseeing all aspects of development from conception to closure with highly detail-oriented approach and efficient resource allocation, timely communications of project updates and potential risks with stakeholders and business partners, and presentation of actionable solutions for global executive team members. - Collaborated closely with cross-functional teams including client services, creative group, and engineering team to promptly resolve project challenges, and managed global business partners and media agencies to build solid foundation for healthy long-term relationships and profitable growth. - Led clinical trial best practices and study site engagement initiatives across 20+ studies, collaborating with clinical operations and IT teams to develop effective infrastructure and content to reinforce best practices in the areas of trial recruitment, referral processing, data entries, patient interactions, and regulatory compliance to significantly enhance trial performance and patient satisfaction. - Generated 100+ actionable leads and expanded new market reach by attending international conferences/networking events and establishing new strategic alliance partners in Asia, Europe, and Africa. - Grew global vendor and alliance partner network by 50% through proprietary assessment metrics to evaluate vendor/partner capabilities, operational efficiency, strategic profile, and compatibility, building solid foundation for long-term collaboration and profitable growth.
  • Bbk Worldwide
    Clinical Research Business Intelligence Analyst
    Bbk Worldwide Mar 2008 - Jun 2009
    - Accelerated new market entries successfully by spearheading global R&D projects and efficiently managing research vendors to provide comprehensive key insights into more than 30 countries’ business landscapes including industry regulations, infrastructures, challenges, opportunities, and crucial target population profiles.- Developed 50+ comprehensive surveys (global feasibility, country/site selection, pre-qualification surveys), collected primary and secondary data, conducted in-depth interviews and focus groups, and generated impactful research reports and solutions for Global Research Division, significantly increasing success rate of new country penetration and target customer reach. - Enhanced team productivity in the Global Research Division by implementing adaptive research guidelines and encouraging team members’ inputs to enable project completions ahead of deadlines.
  • Workforcelogic Llc
    Google Mobile Application And Advertising Evaluation Specialist
    Workforcelogic Llc 2015 - 2016
    - Provided assessment and feedback of the effectiveness of application designs/content and ad messaging to ensure successful deployment of application products and online advertising on Google platforms.
  • Rensselaer Polytechnic Institute
    Doctoral Candidate / Research Fellow
    Rensselaer Polytechnic Institute Aug 2004 - May 2008
    Troy, Ny, Us
    RENSSELAER POLYTECHNIC INSTITUTE, Lally School of Management & Technology, Troy, NY May, 2008Research Fellow, Innovation Management / New Product Development / MarketingResearch Fellow, Entrepreneurship- Provided indispensable research support for a published research project studying the impact of social networks and interpersonal skills on entrepreneurs'​ business performance and their ability to obtain financing. - Analyzed syndicated data and presented research findings and made recommendations at national and international conferences, receiving Best Paper Awards.- Developed new research ideas, managed multiple projects simultaneously including designing surveys, conducting in-depth interviews, collecting primary and secondary data, and generating peer reviews.Teaching Assistant, Marketing Strategy/ New Product Design/Consumer Behavior- Prepared lecture and academic materials, developed college-level examinations, and evaluated 100+ college students' academic performance.- Taught both MBA and undergraduate courses including “Consumer Behavior”, “Product Design & Creating”, and “Managing an Enterprise”.
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  • Apcoa Parking (Uk) Ltd
    Business Analyst
    Apcoa Parking (Uk) Ltd Jan 2002 - Sep 2002
    Uxbridge, Middlesex, Gb
    - Increased revenue in designated facilities by 12% within first six months by conducting thorough market research, analyzing market feasibility and profitability, and devising and implementing effective marketing campaigns. - Expanded new customer base by 20% through onsite visits and incentive programs. - Utilized advanced tracking tools and forecasting software to generate market insights to achieve long-term growth.
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  • Ubs Global Asset Management
    Assistant To Division Manager, Private Equity Group
    Ubs Global Asset Management Jan 2001 - Sep 2001
    Zurich, Ch
    - Provided essential support to Division Manager in monitoring and tracking a team of 20+ financial advisers’ daily performance and productivity.- Managed a large client database of 5,000+ portfolios and developed creative business plans to enhance client participation and investments.- Designed comprehensive marketing plans for Online Investment Services team to effectively target local colleges.
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  • Simmons College
    Assistant, Computer Lab, Media Center, And Library
    Simmons College Mar 2000 - Jul 2001
    Boston, Ma, Us
    - Played a key role in research support, staff assistance, trouble shooting and customer service in various departments on campus as well as made recommendations to improve student overall programs and services.
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  • Shanghai Automation Instrument Co
    Assistant General Manager, Sales Department Of Guangdong Division
    Shanghai Automation Instrument Co Sep 1998 - Nov 1999
    - Conducted extensive market research and developed sales strategies and reports for senior management in Shanghai Headquarters, generating 30+ actionable leads.- Supervised a team of 20 sales representatives and administrative assistants and provided solutions to increase productivity.
  • Guangzhou International Travel Agency
    Global Lead Tour Guide (Certified, Part-Time), International Tour Division
    Guangzhou International Travel Agency Sep 1994 - Nov 1999
    - Developed engaging tour plans for domestic and international tour groups and led the groups to various destinations
  • Panyu Lotus Hill International Golf Resort, Guangdong, China
    Assistant Marketing Manager And Employee Trainer, Business Development Department
    Panyu Lotus Hill International Golf Resort, Guangdong, China Aug 1997 - Aug 1998
    - Conceived and organized a variety of promotional and social events during golf tournaments and holidays.- Designed marketing plans and materials targeting prospective and current club members; expanded customer base by 19% within one year.- Supervised training programs for more than 200 employees; wrote employee English language examinations.
  • Canton Fair (China Import And Export Fair)
    Business Negotiator And Interpreter
    Canton Fair (China Import And Export Fair) Apr 1995 - Oct 1997
    Guangzhou, Guangdong, Cn
    - Successfully negotiated $2.5 million export contracts for three large import and export companies with highly positive performance feedback from companies’ senior management.
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Manli Chen Skills

Market Research Marketing Management Marketing Strategy Business Development Data Analysis Analysis Advertising Project Management Entrepreneurship Public Relations Research Leadership Strategic Planning Microsoft Excel Powerpoint Project Planning Strategy Marketing Communications Cross Functional Team Leadership Business Strategy Market Analysis Clinical Trials Analytics Business Intelligence Business Analysis Vendor Management Training Consulting Social Networking

Manli Chen Education Details

  • Rpi Lally School Of Management
    Rpi Lally School Of Management
    Management--Innovation Management/Npd/Consumer Behavior
  • Simmons University
    Simmons University
    Management/International Marketing
  • Simmons University
    Simmons University
    Marketing
  • Guangdong University Of Foreign Studies
    Guangdong University Of Foreign Studies
    Applied English / International Business

Frequently Asked Questions about Manli Chen

What company does Manli Chen work for?

Manli Chen works for Gilead Sciences

What is Manli Chen's role at the current company?

Manli Chen's current role is Energetic, high-performing, solution-oriented, resourceful, and result-driven Senior Clinical Trial Manager with effective and inspiring leadership skills.

What is Manli Chen's email address?

Manli Chen's email address is mc****@****gic.com

What schools did Manli Chen attend?

Manli Chen attended Rpi Lally School Of Management, Simmons University, Simmons University, Guangdong University Of Foreign Studies.

What are some of Manli Chen's interests?

Manli Chen has interest in Interior Design, Badminton, Reading, New Technologies, Swimming, Health, Community Work, Children, Cooking, Skiing.

What skills is Manli Chen known for?

Manli Chen has skills like Market Research, Marketing, Management, Marketing Strategy, Business Development, Data Analysis, Analysis, Advertising, Project Management, Entrepreneurship, Public Relations, Research.

Who are Manli Chen's colleagues?

Manli Chen's colleagues are Anandaroop Dasgupta, Ph.d., Anisha Suri, Phd, Christina Monica, Mba, Jose Carlos Bianchini, Tracie Rosencrance, Nrupen Kumar, David O'rahilly.

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