Anna Prado Email & Phone Number

São Paulo, Brasil

- Direct and manage the delivery of all required start-up contracting activities for selected sponsors and for complex studies or multi-protocol programs. - Serve as liaison for non-specific projects for top clients.- Support of pre-award activities, oversight of the scope of work, budget and resources, including line management responsibilities.- Accountable for specialist legal, operational and financial contracting support provided to study teams, as applicable to site agreements, to facilitate efficient business development and initiation and maintenance of clinical trials, whilst ensuring compliance with regulatory requirements and local laws.- Responsible for the oversight and development of investigator grant estimates, payment schedule and contract templates, including implementation and maintenance of overall site contracting strategy, contracting systems, tools, processes and training materials.- Assess and review the contracting landscape and oversee the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support projects and the wider company.- Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreements.- Report contracting performance metrics and out of scope contracting activities as required.- Lead and own specific department initiatives, services, and/or account performance, including process improvements.

São Paulo E Região, Brasil

- Responsible for overall site contracting strategy of clinical trials- Key areas of responsibility are the same as those listed below for Contract Manager on a larger scale.

São Paulo E Região, Brasil

- Direct and manage the delivery of all required start-up contracting activities for selected clients and for complex studies or multi-protocol programs as determined by either the agreed algorithm or the client’s requirements, including pre-award activities.- Responsible for the development of complex investigator grant estimates, contracting strategies and proposal text to support the proposal development process.- Develop contract and budget templates and contracting systems, tools, processes, and training materials for selected clients and complex studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.- Provide specialist legal, operational and financial contracting support to facilitate efficient business development and initiation and maintenance of complex clinical trials, whilst ensuring compliance with regulatory requirements and local laws.-Ensure collaboration, including communication with clients, stakeholders and Regulatory/Start-Up regions and countries, to successfully deliver the agreed project scope in compliance with client requirements and/or the Regulatory/Start-Up Management Plan.-Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.-Assess and review the contracting landscape and contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company.-Work with Quality Management to ensure appropriate contract management and quality standards.- Mentor and coach colleagues and provide technical guidance both within and outside the project.-Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans.-Take a lead role in developing long-standing relationships with clients.

São Paulo E Região, Brasil

-Global coordination of site contractual activities;-Develop contracting strategies, contract templates and negotiation guidances;-Develop long standing relationships with customers, and primary interface role in terms of site contracts (global point of contact for key accounts).-Provide contractual support to project leads, local contract negotiators and others;-Provide trainings regarding contractual Process, negotiation parameters, fallback, project guidelines and others-Ensure overall contracting efficiency and adherence to project timelines and financial goals;-Maintaining relationships between Contract Team and internal stakeholders (Project Management, Start-up, Learning&Development, Contracts&Proposals, Investigator Payments Administration, Legal).-Report contracting performance metrics and out of scope contracting activities as required;-Create core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.

 Regional coordination of site contractual issues for Latin American countries. Participation in global key accounts for Contractual and Negotiation strategies. Development of site contract templates and further contract related documents (fallback guidances, contract amendments, Letter of Agreements, etc). Provide trainings to Clinical and Start-up teams to develop skills for contract negotiation. Support to Project Managers, Clinical/Start-up team and Sponsors in order to solve any issues related to contractual matters. Development of tools and procedures to improve the overall quality and efficiency of services provided by Investigator Contracting Services department.

  Regional Lead for Latin American countries during Site Start-Up phase of studies.  Liaison between the Sponsor and the internal team in order to establish the necessary requirements for the Start-up activities and also to guarantee the compliance of deadlines established for the site’s initiation. Development of operational strategies and parameters in order to carry out the activities with the objective of initiating the research sites. These activities include: site identification, submission of dossiers to the Ethics Committees, review and negotiation of contracts and budgets and collection of regulatory documents for the investigational product release. Leadership and monitoring of Start-up team in order to meet studies deadlines as well as to guarantee the quality of the activities and adherence to the standard operating procedures and work instructions.  Support and orientation to the Start-up team in the resolution of issues related to the study sites.*Lead and Specialist roles managed simultaneously.

 Activities related to the inception period of the clinical trials in accordance with local regulations, standard operating procedures and project instructions under the supervision of a regional lead. Activities including site identification, submission of dossiers to Ethics Committees, collection and review of regulatory documents and negotiation of contracts and budgets with research sites. Coordination of the translation of essential documents to the studies such as Protocols and Investigator Brochure. Translation of regulatory documents and clauses of clinical trial agreements.

Assistance to study teams in order to prepare regulatory dossiers and project submission to Ethics Committees in accordance to applicable local regulations, standard operating procedures and project instructions beneath the supervision of a regional Lead.Support to research sites to solve issues in order to initiate the study.Assistance to Project teams to identify potential research sites. Preparation and distribution of study documents to research sites, correspondence dispatch, follow-up and communication with sites, support to control and maintain study files and translation of documents.

 Preparation and collection of documents to the import process of study drugs and materials required to the conduction of clinical trials.  Preparation and dispatch of study documents to research sites.  Preparation of regulatory dossiers to ethical and regulatory submissions.  Development of Informed Consent Form Templates.  Translation of regulatory documents.

 Technical adaptation of Patents with chemical, biotechnological and pharmaceutical applications in compliance with national regulations. Analysis of patentability criterias. Elaboration of petitions to defend the patentability of a patent application in accordance to local legislation.  Translation review of technical texts. Search of patents and bibliographies in national and international databases.

Postgraduate In Research And Development Of Cosmetic Products, Advanced Cosmetology

Degree In Pharmacy-Biochemistry, Pharmaceutical Sciences