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Lilly (company)


Posted on : 02 June 2017

Project Description

Региональный офис / В офисе
Лилли является ведущей инновационной фармацевтической компанией, которая вот уже более 135 лет остаётся приверженной разработке препаратов, направленных на эффективное лечение целого ряда заболеваний, которые ранее считались не излечимыми, а также помогающих значительно улучшить качество жизни пациентов по всему миру.
Компания занимается исследованиями и разработкой фармацевтических препаратов, направленных на удовлетворение медицинских потребностей пациентов в области эндокринологии, онкологии, психиатрии, инфекционных заболеваний, неврологии, кардиологии и урологии.

Ukraine, Kiev


The mission of the Site Activation Management (SAM) is to provide regulatory expertise to customers through ownership of site activation, focus and alignment on the objectives and priorities of the Business Units, and exceptional communication. In carrying out this responsibility, the SAM Associate will be responsible of the site activation of clinical investigator sites, negotiation and processing of regulatory and applicable operational documents to ensure ER ready, as well as the management of all applicable regulatory and operational aspects of ongoing study conduct.

SAM Associatewill provide operational expertise to Regulatory Agencies (MOH) and Central/Independent/Site's Ethical Review Boards (ERB) activities. SAM Associatewill be the main contact with MOH/ERB/other applicable entities and will provide technical and operational expertise for study feasibility, site evaluation process, submissions and inspections.

SAM Associatewill ensure effectively support to Clinical Operations team like site activation activities through study initiation to study closure.

SAM Associatewill ensure that essential clinical study documentation within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards and Procedures.

Key Responsibilities:

Regulatory delivery/Relationship

·Single point of contact for MOH and National/Independent/Site's ERB (if applicable) from start up to closure of clinical trials.

·Provide historical site activation data to enhance site selection discussions ensuring the appropriate sites are participating in the study

·Prepare and manage regulatory submissions to support clinical trials/non-interventional studies (if applicable) for both internal and external clients

·Coordinate of translation process for all the required trial documents and oversight of the quality of final documents.

·Responsible for preparing the country/Site study-level ICF as well as revising as a result of protocol amendments, risk profile updates, etc. in a timely manner.

·Interact and influence collection of required regulatory documents for investigative sites

·Drive timeliness for ERB/MOH submission for trial-level regulatory package as well as negotiate as required

·Develop and maintain relationships with MOH/ERB where applicable.

·Identify potential issues and, anticipate current trends related to regulatory/ethical issues and create plan to mitigate them.

·Ensure that required documents for importation/exportation of IP and non-IP are obtained from regulatory body as applicable.

·Ensure country level regulatory requirements within internal databases (eg. Requirements for the initiation of Trials in Affiliates)

·Maintain active relationships and/or memberships with applicable research and disease-state organizations, if applicable.

·Communicate site-level site activation updates to sites and appropriate study team members as appropriate

·Collaborate with the Clinical Research Administrator (CRA), Clinical Development Consultant (CDC), Lead SAM to declare site regulatory and site readiness for enrollment.

·Collaborate with the Clinical Research Administrator (CRA), Clinical Development Consultant (CDC), Lead SAM to manage site activity/performance during the site activation and maintenance phases of the trial

·Understand, comply, and reinforce local regulations, laws, and guidance (e.g., ICH), Medical Quality Systems (MQS) Standards and Procedures, and Good Clinical Practices (GCP)

Administration and Clinical Operations Support

·Responsible for maintenance of study Trial Master Files and any other internal reporting systems, as applicable

·Responsible for ensuring the affiliate level binder is inspection ready at all times

·Prepare submission files

·Ensure sites receive Investigator Trial Master File ( iTMF) by site ready for SIV

·Prepare documentation for close out and archive in-house files

·Arrange for destruction of “non-archive” materials post study

·Assist Clinical Operations Manager, Team Leader, Lead SAM, Clinical Development Consultant as required to run relevant reports.

·Responsible for coordinating Access Control of Study Systems

·Update and track country study-level tasks for site activation within systems.

·If applicable, assist in meeting logistics and preparation of presentations

·Participate in regional meetings and share best practices