Set-up share point, public drives, Microsoft teams, etc.
Enter feasibility tracking information to Client Clinical Trial Management System (CTMS)
File Site qualification follow up letter submission in Trial Master File (TMF) staging area
Support to Clinical Trial Manager (CTM) to inform Trial Documentation Service (TDS) about trial events to trigger document collections from sites
Support CTM with administrative aspects in managing the importation and release of Investigational supplies (communication and scheduling, obtain Import Licenses) (CTM to release green light, Clinical Research Organization (CRO) supposed to support all other administrative but if not covered by CRO, to be supported by CTA)
Support the coordination of Investigational non-drug supply with the Clinical Supplies (if not possible by CRO)
Co-ordinate translations of documents after review/translation (approvals, applications, advertising, patient materials, Informed Consent Forms (ICFs) etc.) and submit for TMF filing
Support for site contract preparation/negotiation/execution (CTM provides template, CRA responsible for site adaptation)
Update Client CTMS: add sites; site staff; event dates; ICF versions; applications; initiation checklists; update trial team members
Set up Paper Trial Master File if applicable
Qualifications
Ability to collaborate with internal team members/functional lines, CROs, vendors and sites
Good oral/written communication, organizational, interpersonal, and sound problem-solving skills
Advanced presentation skills
Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and consistently performs high quality work
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS)
Able to multi-task under very limited direction, work independently and seek / receive guidance when necessary
Effective time management skills in order to meet study needs, team objectives and department goals
Proven ability to work across cultures
Ability to successfully work in a “virtual”team environment which may be matrixed organization
Proficient in written and spoken English language
Proficient in local language, as required
Knowledge And Experience
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, electronic data capture and eTMF)
Education
Educated to degree level (biological science, pharmacy or other related discipline preferred)
