1-year contract position responsible for all start-up and business support activities for demanding neurology projects Sponsored by Roche, Global Healthcare Company.
University degree, preferably in a medical/science-related field
Previous job experience demonstrating knowledge and understanding of clinical trials, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in Ukraine
Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork
Able to make effective decisions, self-motivated, assertive, and displays initiative
Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility
Demonstrated computer literacy, usage of MS Office software, web-based systems and databases
Ability to communicate clearly and accurately in both written and spoken: Ukrainian, Russian and English
Readiness to travel domestically and abroad, if necessary
Main Responsibilities and Accountabilities:
Ensures adherence and compliance with local regulations and internal procedures.
Executes assigned start-up and business support in assigned protocols:
Obtains regulatory Clinical Trial Application package and relevant site documents, prepares required translations, collates submission files ensuring quality and compliance with local regulations, submits to RA/LECs, supports communication with RA and obtains RA opinion. Uploads/stores documents as required. Up-dates relevant systems and tracking-tools.
Prepares country level Informed Consent Form (ICF). Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
Accountable for end-to end contract preparation and supporting contract negotiations (including commercial and financial matters) with all stakeholders, including resolving and expediting contract matters
Supports procurement and logistics of comparator/background/concomitant therapy and study-related materials (execute contracts and payments, communicate costs, archive documents)
Provides suggestion of complete range of service providers in accordance with scope of work as per protocol (e.g. computer tomography, bone scan, etc.) and communication to a study team
Provides oversight, coordinates review and approval of the amount of work/amount payable within scope of contracts; manages invoices and payments
Maintenance of relevant trackers (e.g. contract tracker, payment tracker, service providers tracker)