1. Prepare and/or coordinate the preparation of project / study materials for internal and / or with vendors such as:
o Consistent and collaborative communication to internal (CSM, IMM, CO – SLM, CLM, CRA, etc.) and external partners (CRO, Laboratory, etc.)
o Creation and sending communications materials to countries and/or study sites (e.g. study document updates, etc.)
o Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return. (i.e. CDAs, CVs, IRB-IEC documents such as approvals, HA and EC submissions, renewals, Investigator Site Files, membership list and other study agreements)
o Submission of IRB – IEC documents for approval as in-house CRA (e.g. CSR submission and EOSPDF management)
o Set – up and maintenance of study specific internet based forums, such as study websites, SharePoints, etc…
o Coordination of communication of project/study status to various levels of management
o Managing and maintaining study information documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites, etc…
o Support the teams with ongoing conduct of studies, at all milestones
2. Organization, maintenance, reconciles and archiving of paper or/and electronic Trial Master Files (eTMF) and assistance with eTMF administrative support activities.
3. Participate and support audits (Bayer QA), inspections (Regulatory Authorities) and verification of TMF. Ensuring the quality, completeness, availability and quality of the clinical study documents in the Trial Master File to enable final compilation of the documents for regulatory submissions and marketing approval of new medications and medical devices. Participate and support quality checks of the Trial Master File.
4. Maintain operational tracking and reporting systems and tools: e.g. YourDOCeS (invoices), IMPACT (updates for planned/concept studies), ShareDoc (eTMF documents), Microstratgy, etc... Development study specific tracking systems based on study team needs.
5. Provide meeting coordination for the global / local clinical and study team members (StM, SLM,GCPM, IMM, CLM, LM, etc…) in scheduling, agenda, presentations, arrangements, minutes, and action item tracking including global and regional investigator meetings, global/regional monitor training meetings (if applicable) and advisory committee meetings as requested by GCPM/GCL
6. May need to provide financial support by tracking and creating site / vendor invoices and payments
7. Will function as a super-user for systems, tools, and/or processes, will act as a technical expert.
8. Oversight IMP destruction process according to SOPs and relevant regulation. Coordinate IMP label approval process(In case of taking local contact person for IMP label approval process). Track info about supplied IMPs and enter data into relavent system(UlTra) to support disclosure reporting
9. Provide expertise in non-project activities.
1. Bachelor’s degree (or equivalent) with 0 – 2 years of relevant experience.
2. Skill set:
- Understanding of clinical development and global operating processes of drug development
- In-depth knowledge of ICH-GCP and international regulations