Description
RESPONSIBILITIES:
Briefly describe the major duties and responsibilities for which the job is held accountable (what the job does, why is it done/impact)
- Interact with Project Leaders and Process Readiness:
- Lead meeting to evaluate and confirm project team deliverable for Quality Document
to create, review and revise corresponding Quality Document (including related supporting documents, process maps etc)
- Perform peer Quality Control on the Quality Document
- Ensure consistency/harmonization of processes by following quality document templates, writing rules and quality control checklist.
- Respect the quality Document plan and timelines to ensure timely production of Quality Document deliverables (including related supporting documents, process maps etc)
- Participate, when appropriate, to the communication prepared at time of Quality Document release
- Regularly track and report assigned activities
- Attend regular meetings giving status updates, reporting and escalating any issues to QDoc Factory
Knowledge And Skills:
- Strong knowledge of international good clinical practices (ICH) and thorough understanding of current regulatory requirements (FDA, EMEA) related/applicable to the conduct of clinical trials.
- Strong knowledge and proven experience in translation of business processes into Quality Document.
- High degree of personal accountability and commitment.
- Ability to prioritize assignments in accordance with assigned project deadlines.
- Excellent communication and collaboration with project teams and POnA partners.
- Strong facilitation skills: ability to lead effective cross-location through discussions on complex and potentially controversial topics.
- Ability to anticipate problems/changes impacts, consequences, and delays; work proactively and take the initiative for corrective measures.
- Ability to recognize issues that may require escalation to management level.
- Ability to multi-task, handling a wide range of assignments in parallel and dealing with urgent issues as they arise.
- Excellent written and verbal skills.
- Competent in English (both written and verbal) to interact effectively in an international environment.
- Ability to read, understand and interpret process maps