Projects manager

Была больше месяца назад

По договорённости

Соискатель скрыл дату рождения

Москва

Занятость

полная занятость

Гражданство

Россия

Контакты

Телефон

Почта

Будут доступны после открытия

Фото, имя и контакты доступны только авторизованным пользователям

Опыт работы 26 лет и 8 месяцев

- Май 2012 – работает сейчас
- 13 лет и 7 месяцев
Project Manager
Glenmark Pharmaceuticals LTD, Москва
http://www.glenmarkpharma.com
Обязанности и достижения:
Conducting a full cycle of Phase I-IV Studies Preclinical, bioequivalence studies, Dissolution test Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures Anticipating risk and implementing mitigation strategies Managing study team assignments, accountability and resource requirements Preparation and collection of primary information, conducting interviews of project stakeholders to prepare functional requirements for the creation of information systems, commissioning and support. Selection of vendors, holding a tender Execution of Technical Specifications according to GOST, updating of project documentation for the project team Development of functional specifications, probable solutions, descriptions of business processes for the preparation of project documentation and transfer to the systems development Discussion of the methodology of information systems testing Conducting acceptance tests and preparing information systems for commissioning. Performing the tasks of the project administrator Preparation and updating of the project plan and project documentation Preparation of contract documentation, support of project and contract document management (control of deadlines and fulfillment of obligations) Control of completeness and quality of obligations fulfillment Administrative support of the complex of tests (acceptance tests) and commissioning Administrative support of work processes, advanced trainings of personnel — users for effective systems use and goals achievement Ensuring the study budget is managed proactively including scope changes and financial systems are accurate Document flow Acting as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits Co-monitorings, Sponsor audit Define monitoring requirements including components of Risk Based Monitoring Selection, qualification, training, contracting of the necessary vendors for the study, including the search for the centers necessary for the purpose of the study Reporting Regulatory authorities submission - MOH, Ethics Committees, assessment of compliance of Ethics Committees with international GCP standards, work on request Creation of research-specific procedures, instructions Trainings for the staff Data monitoring and validation of interim data at the clinical center level Monitoring the timing of the study, tracking the timing of recruitment to the study Control of compliance of the clinical trial procedure with local legislation, ensuring compliance of the conducted studies with the protocol, schedule and accepted international quality standards Work with insurance companies in the current mode and in the course of judicial proceedings Experience of passing international audits, Roszravnadzor audit
- Июнь 2008 – май 2012
- 4 года
Senior Clinical research associate
"F. Hoffmann-La Roche LTD."
http://www.roche.com
Обязанности и достижения:
Guidance over specialists in monitoring of clinical trials, Interaction with CRO to provide research centers with all the materials necessary for CT, control of the work of CRO Coordination of the clinical trial process: Examination and selection of Investigational centers, KOLs, initiation, monitoring of the work of centers, close out activities, regular reporting on the results and provision of appropriate medical documentation Preparation and collection of documents for submission to regulatory authorities – MOH, Ethics Committees, assessment of compliance of Ethics Committees with international GCP standards, communication with ethics committees Collection of the necessary documents for center file and other, ethical committees, obtaining approvals, creating research-specific procedures, instructions Trainings for the staff (CRO, center and monitors) Ensuring control over the storage and handling of the products under investigation, as well as ensuring their accountability Data monitoring and validation of interim data at the clinical center level Control over the timing of the study Control of compliance of the clinical trial procedure with local legislation, ensuring compliance of the conducted studies with the protocol, schedule and accepted international quality standards Communication with suppliers, collection of documents for customs, delivery control Work with insurance companies Participation in conferences, symposiums, congresses Maintaining current data entry and ensuring regular reporting Monitoring of international studies Timely reporting and tracking of identified adverse events during the study Submission to the Ministry of Health Experience in passing international audit, Roszravnadzor audit
- Июнь 2005 – июнь 2008
- 3 года и 1 месяц
Clinical research associate
Roche Moscow LLC
http://www.roche.com
Обязанности и достижения:
Coordination of the clinical trial process: Examination and selection of Investigational centers, KOLs, initiation, monitoring of the work of centers, close out activities, regular reporting on the results and provision of appropriate medical documentation Collection of documents or center files, ethics committees, obtaining approvals, communication with ethics committees Trainings of the investigators Ensuring control over the storage and handling of the products under investigation, as well as ensuring their accountability Data monitoring and validation of interim data at the clinical center level Control of compliance of the clinical trial procedure with local legislation, ensuring compliance of the conducted studies with the protocol, schedule and accepted international quality standards Communication with suppliers, collection of documents for customs Participation in conferences, symposiums, congresses Maintaining current data entry and ensuring regular reporting Monitoring of international studies Timely reporting and tracking of identified adverse events during the study
- Декабрь 2004 – июнь 2005
- 7 месяцев
Sales Department Head Assistant
Smile LLC
Обязанности и достижения:
Company sales analytics Brand sales analytics Calculation of the company's profit Preparation of financial reports Monitoring the implementation of sales plans Control of the availability of products from sales representatives, timely replenishment of products, interaction with the warehouse Control and timely certification of products
- Апрель 1999 – декабрь 2004
- 5 лет и 9 месяцев
Postgraduate student, researcher
Russian Academy of Science
Обязанности и достижения:
Research work, Post graduate student Direct participation in Russian and international conferences ((Nantes, France, 2001; Toulouse, France, 2001; Saint Petersburg, Russia, 2002; Penza, Russia, 2003; Sorrento, Italy, 2004) Translation of articles, incoming and outgoing correspondence, technical instructions from Russian into English and from English into Russian Writing reports and articles in Russian and English Correspondence in English with Western partners Registration of Russian and foreign grants, cooperation agreements Organization of work of subordinate employees Organizing Conferences
- Февраль 2004 – сентябрь 2004
- 8 месяцев
Academic staff
Glasgow University
Обязанности и достижения:
Research work, Post graduate student Translation of articles, incoming and outgoing correspondence, technical instructions from Russian into English and from English into Russian Writing reports and articles in Russian and English Registration of Russian and foreign grants, cooperation agreement Creating presentations for trainings

Образование

- Высшее образование
- 2004
Postgraduate study of the Kazan Branch of the Russian Academy of Sciences
Факультет: Specialty – “Physiology and biochemistry of plants”.
Специальность: PHD
- Высшее образование
- 2001
Nizhny Novgorod State Linguistic University named after Dobrolyubova
Факультет: “Linguist, English teacher”
- Высшее образование
- 2000
“Genetics” Kazan State University
Факультет: Genetics

Обо мне

Дополнительные сведения:

Decision-making, collaborative, team-oriented Jira, Confluence, 1C, Hamiltom, Directum, Electronic document management, CRM, Ведение переговоров, Управление проектами, Управление персоналом, Заключение договоров, Работа в команде, Деловая переписка, Английский язык