Sr Cta

This role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents.

Assist with daily workload planning.

This is a **Hybrid** role - office based in **Paris**

**Trial and site administration**:

- Manage SIP, Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

**Document management**:

- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents

**Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to**:

- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
- Publish study results for GCTO and RA where required per local legislation

**Qualifications**
- Relevant work experience in a clinical environment or medical setting
- Working knowledge of the principles of Good Clinical Practices (GCP)
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
- Excellent interpersonal skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients