Clinical Quality Manager
il y a 12 heures
Hobson Prior are currently looking for a Clinical Quality Manager to join a fantastic pharmaceutical organisation on a permanent basis with the ability to work remotely from anywhere within Belgium, France or the UK. Our client is focused on evolve ground-breaking therapies to treat cancer via improved immune response.
Please note that to be considered for this role you must have the right to work in this location.
**Key Responsibilities**:
- For this role, you will guide the company in planning support teams for trial-connected GCP sponsor and/or site-connected inspections.
- Assist and organise the development of responses to GCP audits and inspections as well as guarantee suitable CAPA execution.
- You will execute a quality-by-design approach from initial protocol through clinical study document.
- Offer contributions as well as agree on trial-specific monitoring plans.
- Enable suitable quality problem escalation rendering to all suitable change management procedures.
- Any other assigned duties.
**Key Skills**:
- Project management capabilities.
- Capable of resolving issues.
- Able to think tactically.
- Works well within a cross-functional team setting.
- Communication skills both verbally and in writing.
- Deliberation abilities.
- A self-starter who works well independently.
- An organised individual with a high attention to detail.
**Requirements**:
- Educated to a degree level in a pertinent discipline or obtained work experience in a pertinent healthcare field.
- At least 5 years of experience within clinical research.
- Know-how and comprehension of clinical development programs, clinical trial procedures and quality management and control tools.
- Comprehension of suitable US and global GCP guidelines/regulations to enable the comprehension and affect of discoveries of audits both internally and externally.
- Familiarity with FDA proposals as well as EMA proposals.
- Acquaintance with designing trials to plan for inspection promptness.
- Prior involvement in a therapeutic area, connected to design of trials, TA-specific clinical examinations and medical practice.
- Familiarity with delivering efficient CAPA management solutions.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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