Senior Clinical Data Manager
- Employer
- RBW Consulting
- Location
- United Kingdom (GB)
- Salary
- 45000 - 60000
- Start date
- 15 Sep 2021
- Closing date
- 15 Oct 2021
View more
- Discipline
- Data Management / Statistics, Clinical Data Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Senior Data Manager
Ashley Clarke @ RBW consulting is currently recruiting for a Data Manager to work for a European CRO. They quality trial management multi-country trials. Their approach is very innovative and look for the same flare in their employees. They cover all phases of drug related trials, as well as clinical investigations for medical devices and diagnostic devices. The role is permanent and candidates can be based In UK or In Europe and will be able to work from home.
Responsibilities
The Senior Clinical Data Manager reports to the Data Management Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines.
The Senior Clinical Data Manager promotes the introduction of digital technologies and innovative data processing tools and acts as a mentor for junior staff.
Job Profile
Ensure data is managed in compliance with applicable standards (e.g. CDISC), regulatory guidelines.
- Prepare Data Management documents (CRF, Data Management Plan, Data transfer specifications, etc.)
Design the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, and the study team;
- Prepare and validate the eCRF/clinical databases and related tools;
- Perform data cleaning activities;
- Perform coding activities of medications and medical terms using medical dictionaries;
- Perform SAE reconciliation when required;
- Manage database locks and freezing before data analysis;
- Prepare, maintain, and archive data management documentation;
- Perform quality controls according to the Data Management Plan;
- Liaise with Sponsor and external stakeholders regarding data management activities;
- Track activities and milestones to ensure timely project deliverables;
Organize/perform trainings for project team
- Collaborate in establishing and maintaining SOPs related to Data Management;
- Collaborate in establishing and maintaining document/programming standards;
- Promotes the introduction of digital technologies and innovative data processing tools and acts as a mentor for junior staff.
Qualifications / Experience
At least 3 years of experience in CRO, biotech, pharma, research institutes in similar role;
- Solid knowledge of clinical data management and HA requirements pertaining to pharmaceutical research and specifically to Data Management;
- Digital skills and good knowledge of FDA 21 CFR Part 11 and system validation;
- Solid knowledge on relational databases and programming languages;
- Knowledge of CDISC standard specifications;
- Strong commitment to quality;
- Flexibility and propensity for innovation;
- English language (fluent reading, writing and verbal skills);
- Planning and organizational skills;
- Communication skills;
- Result-oriented;
- Team-working oriented.
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
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