Precision Medicine Group
More roles at Precision Medicine GroupSenior Clinical Data Manager
Remote role where the employee must remain based in a particular country.
Poland only
From the employer's advert: We can consider candidates based in the Poland, Hungary, Romania, Serbia or Slovakia.
Employer listed it 5 days ago · Added 4 weeks ago
Been open since 4 weeks ago, still being checked, but it has been live a while.
Salary
Not stated
Location
Poland only
Timezone
GMT
Contract
Full-time
Experience
Senior
Category
Data
The employer did not publish a salary, and we have too few comparable roles to estimate one.
What the advert says
Quoted word for word from the employer's advert. Where it says nothing, we say so.
- Working hours
- Not mentioned in the advert
- Where you can work from
We can consider candidates based in the Poland, Hungary, Romania, Serbia or Slovakia.
- Contract
- Not mentioned in the advert
- Experience asked for
8+ years’ experience as a Sr.
- Pay
- Not mentioned in the advert
Remote flexibility
Work from home
This is a remote role, but the employee must be based in Poland. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Remote, Hungary; Remote, Romania; Remote, Serbia; Remote, Slovakia; Remote, United Kingdom, United Kingdom (London)"
- Job description states: "based in the Poland"
What Nomaders makes of it
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
Before you apply
Experience: employer states
Written as a nice-to-have
- “Oncology experience preferred”
Questions worth asking: Nomaders interpretation
- No pay is stated. Ask for the salary range before investing time in interviews.
- The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.
Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.
About the role
We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team. We can consider candidates based in the Poland, Hungary, Romania, Serbia or Slovakia.
Position Summary:
The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.
Essential functions of the job include but are not limited to:
Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
May perform quality control of data entry
Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications
Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
Review and query clinical trial data according to the Data Management Plan
Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
Run patient and study level status and metric reporting
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaises with third-party vendors such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables
May assist with SAS programming and quality control of SAS programs used in the Data Management department
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
Requirements
- ·Bachelors and/or a combination of related experience
- ·8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company
- ·Set up and Database migrations experience
- ·Oncology experience preferred
- ·Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Precision Medicine Group, mentioning your remote working experience and working hours (GMT).
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 28d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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