Clinical Data Integrator

2 weeks ago

Welwyn Garden City, United Kingdom CK GROUP Full time

CK Group have an excellent opportunity for a Clinical Data Integrator to join a fantastic biopharmaceutical company on a 12 month contract basis. The client is a genuine world leader in this field. The role has been deemed to be outside IR35 and workingoptions of Ltd company, umbrella and PAYE via CK are all available.
This is a hybrid role and ideally you would need to attend the client's office in Welwyn Garden City twice a week.

**Responsibilities**:
As Clinical data integrator you will:

- Lead and contribute to a use case datamart, interacting with members of the use-case team to discuss, assess requirements for ADaM dataset creation. Expected to be the SME for ADaMs in their use-case
- Lead in the development and QC of pooled ADaM datasets
- Develops and maintains ADaM specifications ensuring consistency with company Data Standards where possible, with the ability to deal with the ambiguity of Secondary data usage
- Working closely with the SDTM curator using the analysis data requirements to guide the SDTM delivery, fostering an exchange of ideas and ensuring internal standards are met
- Develops software to support pooling of clinical trial data.
- Analyses business processes, develops, tests and validates standard software solutions to support these processes.
- Establishes, promotes and maintains strong effective working relationships with stakeholders

**Essential criteria**:

- 5 years working experience in ADaMs.
- Excellent knowledge in the development and implementation of complex data manipulation algorithms.
- Good knowledge in the programming of analyses
- Good knowledge in the principles of software design
- Excellent knowledge of data modelling and relevant standard data models used to capture clinical study data
- Good knowledge of the drug development process
- Good knowledge of GCP and regulatory guidelines
- Good knowledge of methods used to analyse clinical study data
- 5 years experience of programming using SAS, R or other statistical packages
- 5 years experience of programming analyses of clinical study data

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54369 in all correspondence.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

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