Senior Clinical Data Manager (Home-Based, anywhere in Europe)
Hobson Prior is seeking a Senior Data Manager to join a global team. This role involves managing data-related tasks for assigned studies, ensuring they are completed on time and within budget.
The successful candidate will work closely with sponsors, clinical and statistics teams to develop data collection specifications.
This role also involves leading the data management team and acting as the main point of contact for the sponsor's regarding data management.
Responsibilities :
- Oversee project milestones from study start to database delivery.
- Contribute to protocols with Data Management input.
- Design the Case Record Form and guide the approval process.
- Develop and manage the Data Management Plan, Data Validation Plan and other related documents.
- Validate the database and computerised checks.
- Define the User Acceptance Test Plan and execute test activities for EDC studies.
- Prepare guidelines for CRF completion and data-entry.
- Manage term coding for clinical studies and handle queries.
- Manage data cleaning process and query management.
- Perform data integration of CRF and non-CRF data.
- Perform reconciliation of external data.
- Monitor study data progress reports and manage any issues.
- Lead the data management team and coordinate work assignments.
- Contribute to training for new starters.
- Follow SOPs and industry standards in day-to-day activities.
- Make recommendations for process improvements.
- Maintain communication with the sponsor and represent Data Management in meetings.
Key Skills and Requirements :
- A degree in pharmaceutical or life science or another related field.
- Previous data management experience.
- Deep knowledge of Oncology and in CRO.
- Expertise with either Medidata or Merative Zelta.
- Familiarity as a Lead Data Manager with hands-on work like writing DMP, DVP and query management etc.
- Experience with management of non-CRF data.
- Knowledge of pharmaceutical industry guidelines like ICH, GCP, etc.
- Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent.
Interested or know someone who might be? Reach out to Antony Serrecchia using the following :
01892 337420
Apply now :
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV.
Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
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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