Site Contract Leader

Вакансия № 1-22230244 в городе (населенном пункте) Киев от работодателя "Parexel International" на сайте www.RABOTKA.com.ru "Агрегатор вакансий".

Город, регион, страна: Киев, Украина (населённый пункт) места работы.

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Компания: Parexel International (организация, фирма, ИП);

Логотип (бренд, торговая марка, эмблема) компании (организации, фирмы, ИП):

Репутация работодателя Parexel International:

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Зарплата: по договорённости;

Требования к работнику:

Дополнительные требования:
не указаны

Дополнительное описание вакансии:
Responsibilities: The main responsibility of the Site Contract Specialist is the negotiation of study specific generic and country Clinical Site Agreement (CSA) templates with the Sponsor and support the PL in the negotiation of country budgets with the Sponsor as well as providing the local CTS/CRA with required CSA country templates. Further, the responsibilities include managing CSA activities and liaising with PL, GRO Lead and the Sponsor to ensure that the CSA start-up deliverables are met. The Site Contract Specialist is responsible for the coordination of the local CTS /CRA working on CSAs on a project level for all countries in his/her region. Act as functional Specialist on projects and develop study specific CSA strategy Agree and negotiate study specific generic and country CSA templates with the Sponsor and support the PL in the negotiation of country budgets with the Sponsor Gather relevant study information from PL Discuss and finalize specific country CSA templates with input from Sponsor, PL and GRO Lead if appropriate Upon sponsor approval of the country specific template, store the final approved and complete country template and country budget PMED Communicate CSA strategy, CSA turnaround timelines, CTMS tracking requirements and budget information/updates with the assigned CTS/CRAs Provide agreed study and country CSA templates to local CTS/CRA for country specific adaptation Coordinate interaction between GRO Lead, PL and Sponsor including overall timeline management for CSAs Coordinate overall CSA process with assigned CTS/CRA and status reporting to GRO-Lead/PL Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is up-to-date Maintain comprehensive language tracker Early recognition of areas of potential problems and formulate contingency plans Define solutions strategy of significant CSA changes requested by the site whereas minor administrative changes to be done by local CTS/CRA Evaluate and identify resourcing needs of SSU staff to be assigned on the project and provide performance feedback as appropriate Participate in client, investigator and team meetings Identify and facilitate CSA training needs of local CTS/ CRA Maintain and assure quality of work generated Compile CSA status within a project as agreed with PL and GRO Lead Prioritize effectively and respond to urgent requests within team or sponsor lead Provide mentoring and coaching to CTS staff Resolve negotiation issues that have arisen at the clinical site and escalated from the CTS that cannot be resolved by the CTS after several attempts. Escalate changes that fall outside the documented “fall-back” parameters, if available to the Sponsor or to Clinical Site Agreement Manager as appropriate. Provide internal and Sponsor approval to CTS for signature of the fully agreed CSA according to applicable PAREXEL or Client instructions Maintain a working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, and PAREXEL WSOPs and study specific procedures Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims). Requirements: Experienced CRA, CTS or a senior person with a legal or business degree or other relevant experience, preferably in one of the following environments: Contracting, Clinical Operations, Legal (Paralegal) or in a comparable function in another CRO or pharmaceutical company. Excellent computer and internet skills including knowledge of MS- Office products such as Excel, Word Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability Excellent interpersonal, verbal and written communication skills Ability to motivate both individuals and a team. Ability to successfully work in a “virtual” team environment Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks Shows commitment to and performs consistently high quality work Ability to identify and address issues proactively in a timely manner Ability to take initiative, work independently and delegate Terms: Education Degree in business, legal or life science or other relevant work experience in Contracting, Clinical Operations or in Legal (Paralegal) Language Skills Fluent in written and spoken English in addition to fluency in the local language

Вакансия № 1-22230244 относится к сфере деятельности: "Консультирование" » "Управленческое консультирование".

Вы можете перейти к просмотру актуальных предложений работы выбранного населенного пункта с учетом сферы деятельности вакансии № 1-22230244: "Консультирование в населенном пункте текущего места труда" » "Управленческое консультирование в населенном пункте текущего места труда".

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(Переходите на веб-страницу сайта-партнёра «Центр Занятости Населения (электронный)» с вакансией № 1-22230244 на должность "Site Contract Leader" в городе (населенном пункте, регионе, стране) Киев, Украина, где находится телефон, Telegram, Skype, Viber, WhatsApp, E-mail, адрес работодателя "Parexel International")