Analyst -TMF Clinical Trail Coordinator

Key Accountabilities

Clinical Trial Coordinators of the Inspection Readiness & TMF Center of Excellence will manage activities within a dedicated Center of Excellence of the Clinical Quality Management team for all clinical studies within GDO across the portfolio. This approach will provide support for study teams to enhance a proactive, simplified, common and solution-oriented support.

The CTCs of this group are not officially part of the Trial Teams, as they are mainly contributing as Center of Excellence support, therefore they will be not listed on the individual Trial Team Lists per study.  

The following key accountabilities describe the general tasks for this role but are not limited to these tasks only. The assignments will be dependent on the individual role level, work experience and performance and differ dependent on the priority of the trial / the program and the volume of the trial size.   

·        Contribute to TMF setup, TMF maintenance and TMF archiving activities (e-TMF and paper TMF) according to ICH-GCP, company SOPs and WIs, as required

·        Contribute to TMF KOM, TMF Plan, TMF setup and TMF placeholder management

·        Conduct TMF Review, Management and Oversight and / or support coordination and direction for TMF related activities to internal and external contributing functions

·        Conduct and coordinate cross-functional eTMF reviews, TMF document upload process and TMF trainings

·        Act as Subject Matter Experts for TMF (internal and external)

·        Use and train different eTMF systems (e.g. Medidata RCM, Wingspan, Veeva Vault etc), the TMF Reference Model Filing Index as well as all associated processes and guidance

·        Perform BREEZE uploads & QC for IND relevant documents, ICFs and EU CTR submission part II documents  (as applicable per study)

·        Support STARTOne document uploads for ISS Studies

·        ISS inhouse file QC & Archiving

·        Act as GDO Subject Matter Expert for relevant group systems (e.g. eTMF systems, eTMF archive and BREEZE) and processes to contributing functions and external vendors, if required

Strategic Impact

Accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles. Supports / coordinates tasks with own responsibility. Solves problems of low complexity independently by identifying and selecting solutions and by analyzing factual information. Impacts the results of own team. Exchanges straightforward information, asks questions and checks for understanding

Candidate’s Profile

Education

·        Requires a graduate background (e.g. Bachelor’s degree) in scientific field plus some professional experience in a clinical research- related position (1–3 years in Clinical Development or equivalent).

Work Experience

·        Good Communication skills (written and verbal)

·        Experience working in a high-volume environment while maintaining both organization and the ability to multitask

·        Good administrative and coordination skills

·        Reliable, conscientious and confidential

·        Able to work independently as well as in a team

·        Good organizational and problem-solving skills

·        Willing to take on responsibility and accountability

·        Ability to work in an international/ multicultural matrix environment

·        Good Time Management & Inter personal skills

·        Support / Coordinate tasks with own responsibility

Job specific Competencies & Skills

·        Good understanding of Clinical Operations & ICH-GCP

·        Good Computer skills including knowledge of MS Office (Excel, Word, PowerPoint), Outlook, TEAMS

·        Good experience with Trial Master File management, including use of eTMF system

·        Good experience with use of a CTMS System

·        Ability to take on role as Subject Matter Expert

·        Ability to present and train new processes

·        Adaptability / Flexibility

·        Critical Thinking

·        Strong Communication Skill

·        Ability to work independently

·        Accuracy/ Quality of work

·        Attention to details

·        Interpersonal skills

·        Business Partnering skills