Caroline Thangavelu
Clinical Contracts Consultant & Strategist: Focused at Accelerating Contracts For Study Start Up at ENGAGE Clinical Contracts Solutions- Claim this Profile
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English Native or bilingual proficiency
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Dutch Professional working proficiency
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Malay Native or bilingual proficiency
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Cross-Cultural Communicator Professional working proficiency
Topline Score
Bio
Paula Pérez
Caroline is a very resolutive and efficient professional. She always takes into consideration that time is at the essence in clinical trial business and halfway solutions are the best approach for resolving contracting issues with counterparts but safeguarding her contractor’s best interest.
Ricardo Collado Medina
During the time we worked together, Caroline was always supportive, paying attention to the legal aspects and providing detailed solutions.
Angela Mollart
Caroline is very pragmatic and has been a pleasure to work with. She always considers the best approach to resolve issues in the most efficient and timely way.
Paula Pérez
Caroline is a very resolutive and efficient professional. She always takes into consideration that time is at the essence in clinical trial business and halfway solutions are the best approach for resolving contracting issues with counterparts but safeguarding her contractor’s best interest.
Ricardo Collado Medina
During the time we worked together, Caroline was always supportive, paying attention to the legal aspects and providing detailed solutions.
Angela Mollart
Caroline is very pragmatic and has been a pleasure to work with. She always considers the best approach to resolve issues in the most efficient and timely way.
Paula Pérez
Caroline is a very resolutive and efficient professional. She always takes into consideration that time is at the essence in clinical trial business and halfway solutions are the best approach for resolving contracting issues with counterparts but safeguarding her contractor’s best interest.
Ricardo Collado Medina
During the time we worked together, Caroline was always supportive, paying attention to the legal aspects and providing detailed solutions.
Angela Mollart
Caroline is very pragmatic and has been a pleasure to work with. She always considers the best approach to resolve issues in the most efficient and timely way.
Paula Pérez
Caroline is a very resolutive and efficient professional. She always takes into consideration that time is at the essence in clinical trial business and halfway solutions are the best approach for resolving contracting issues with counterparts but safeguarding her contractor’s best interest.
Ricardo Collado Medina
During the time we worked together, Caroline was always supportive, paying attention to the legal aspects and providing detailed solutions.
Angela Mollart
Caroline is very pragmatic and has been a pleasure to work with. She always considers the best approach to resolve issues in the most efficient and timely way.
Credentials
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Basics on Regulatory Requirements in Clinical Research Training Certificate
European Centre for Clinical Research Training (ECCRT)Feb, 2022- Oct, 2024 -
Implementing GDPR In Your Organisation
European Centre for Clinical Research TrainingMay, 2020- Oct, 2024
Experience
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ENGAGE Clinical Contracts Solutions
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Netherlands
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Clinical Contracts Consultant & Strategist: Focused at Accelerating Contracts For Study Start Up
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2018 - Present
I help clinical study contract and research start up teams in life sciences companies navigate the complex world of clinical site contracting. Through my service offering, I help companies finalize clinical contracts quickly, orchestrate the global contract management network and promote development of their human capital. I believe we can deliver quality clinical contracts seamlessly and quickly when contracting efforts are streamlined and we remain engaged.
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Clinical Study Contracts Consultant
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2018 - Present
Is your leadership team looking for a business partner to support your company's continuous improvement initiatives or perhaps, is your team looking for a partner to help them manage escalated clinical study agreement issues?WORK WITH AN EXPERIENCED HANDS-ON PROFESSIONAL.I can work with you to design customized "tools" and "roadmaps.” I provide objective feedbacks on your clinical study contract process, models and best practices and will share my experience gained from working in diverse environments to help you make an informed decision for your company. I can also be your trusted team member in the issue resolution process. I will break the issue down into simple terms, help you understand any local background and together, we will find a balanced solution. Show less
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Clinical Study Contracts Strategist
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2018 - Present
Are your clinical study contracts difficult to negotiate because they are "walls of texts," heavily peppered with legal jargon? Are negotiations being held up because your clinical study contract does not reflect the local contracting requirements? Do you find yourself running in circles trying to understand the local contracting practice as study start up time ticks away? Your clinical study contract is essentially structured communication, intended to reconcile the parties' expectations in the research. Contracts negotiators become more confident in the execution of their responsibilities through balanced, relevant and clear clinical study contracting templates and up to date intelligence.DEVELOP A STRONG CLINICAL STUDY CONTRACTS TOOLKIT AS YOUR STRATEGY.I help you speed up clinical study contracts negotiations by making sure that you have the right tools to start off with. With the drafting skills acquired from my legal training and practice, I develop and fine-tune clinical study agreement templates to fit local requirements and make them simple. I believe in using standard business English as all parties to the clinical research process should understand the contents of the agreement. I facilitate the collection of clinical study contracts intelligence data from local contracts negotiators using my cross-cultural communication skills. I analyze the data and manage them to suit your needs.With a strong clinical study contracts toolkit, your contracts negotiators will feel empowered and you keep them engaged. Show less
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PAREXEL
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Associate Director, Legal & Risk Management: Specialized in Clinical Legal Operations
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May 2014 - Jan 2018
In May 2014, I moved into the legal department and was tasked with supporting clinical operations during the research start up phase. I remained responsible for training and managing the clinical trial contract templates and know how for over 50 countries in Europe, Asia Pacific, Latin America, North America, Middle East and North Africa.In this role, I supported clinical teams in resolving operational issues involving clinical trial contracts, investigator payments, confidentiality, patient informed consent, vendor services, patient recruitment and quality assurance. I applied company policies and processes first hand to align with the company's business goals. I also mentored clinical trial specialists and clinical trial contracts leads. My 1:1 mentoring approach that focused on personal connection and developing my mentee's understanding of the subject matter has reduced escalations on patient informed consent queries by more than 75%. Assigned as a subject matter expert for clinical trial contracts, I provided the technical knowledge and practical insight on clinical trial contracting worldwide to the Executive Management to change the company’s clinical trial contracting model to save costs and shorten investigator payment turnaround time.I also led change of the company’s clinical trial contracting model in Russia that has resulted in a more streamlined approach with the company’s global contracting model. Show less
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Consultant Clinical Site Agreements: Specialized in Clinical Contracts Management and Strategy
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Mar 2008 - May 2014
After my time in Centocor/Johnson & Johnson, I was ready to move into a consulting role that is focused on strategic management of clinical trial contracts. This position encompassed all my areas of expertise and knowledge: clinical trial contracts drafting and review, legal(regulatory) research, issue resolution, training and cross-cultural communication.My main task was to streamline the way the company works with clinical trial contracts through templates standardization, written guidance, training and process development, and to provide general consulting for clinical trial contracts and its related operational queries (e.g. queries related to delegation letters, investigator payments and informed consent). During this time, I co-led the standardization efforts and management of the company's clinical trial agreement templates and intelligence data for over 50 countries worldwide. My contract drafting and research skills have produced a library of more than 200 clinical trial contract templates and in-house clinical trial contracting knowledge for countries spread across Europe, Asia Pacific, Latin America, North America, Middle East and North Africa. I also played a lead role in the clinical trial contracts integration process of the company’s 12 newly acquired local affiliates in Asia Pacific through close colloboration with the local management and training plus mentoring of the contracts negotiators. My cross-cultural communication skills, service oriented attitude and enthusiasm in imparting the knowledge I have about clinical trial contracts have made this integration process smooth sailing and built trust with the newly acquired affiliates. Show less
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Senior Contracts Analyst Specialized in Clinical Contracts Negotiations
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Feb 2006 - Sep 2007
This was my first job in the pharmaceutical industry. In this role, my legal training and organizational skills have enabled me to lead negotiations of clinical trial agreements for global clinical studies with ease despite being new to the industry and having a line manager who was based in the United States. I successfully delivered negotiated clinical trial agreements and other relevant legal and corporate documents such as power of attorney, delegation of authorities and intercompany agreements for global clinical study programmes according to the project timelines. This function also required management of contract research organizations (CROs) engaged by the company to support the performance of the research and I led improvement initiatives with the CROs through development and delivery of trainings. I am still in touch with the CRO professionals I have worked with during my tenure at this company and this is a testimony of the relationship and rapport I have built. Show less
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Advocate & Solicitor Specialized in Banking Litigation
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2001 - 2003
As as Advocate and Solicitor of the High Court of Malaysia, I represented international banks such as Citibank and Standard Chartered Bank in commercial and civil litigation matters that included debt recovery proceedings and enforcement. This experience has honed my skills in advocacy, legal writing and analysis of legal documents. I have developed organizational skills and an eye for details by managing the cases assigned to me. Court attendance has also strengthened my communication skills and presentation skills. Show less
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Education
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University of Portsmouth
Master in European Law and Policies -
Legal Profession Qualifying Board Malaysia
Postgraduate Certificate In Legal Practice -
University of London
Law Degree (Honours)
Community
