CLINICAL DATA LEAD

The Clinical Data Lead will be responsible for managing and overseeing the data management activities from start up to close out clinical trials. The selected candidate will work closely with external providers to ensure delivery to time, quality and cost expectations, as well as guaranteeing  data management activities according to ICH guidelines, regulatory requirements, and the company’s standard operating procedures (SOP).

Job Description 

Responsibilities:

  • Provide operational leadership to the planning, execution, collection, and interpretation of all clinical data to the highest quality standards (CDISC)

  • Report status of clinical data management activities to project teams, CDISC implementation and strategy governance of standards in collaboration with internal teams and external providers

  • Provide support to the data preparation for reporting clinical study results for regulatory filings, publications, presentations

  • Internal advise on data management topics like coding guidelines, protocol , CRF design and best practices of eClinical technologies, ie: EDC,eCOA, mHealth,etc.

  • Contribute to develop and implement data management standard operating procedures

  • Oversight CRO data management outsourced activities, including Data Management Plans, Data Management Manuals, Data Cleaning Plans and Metrics.

  • Work with third-party vendors to develop clinical data transfer specifications

Profile 

Experience:

Minimum experience: 3 years managing clinical trial data in a pharmaceutical, biotech, or CRO setting; dermatology trial experience strongly preferred

 

Education:

Bachelor  in Life Sciences or related field

 

Specific knowledge:

  • Solid knowledge in CDISC standards, CDASH and SDTMs.

  • Proficiency in core data management activities (e.g CRF design, CRF annotated review, data edit specifications and data validation, creation of data management plans, expert use of adverse events and concomitant medication coding dictionaries, such as WHO and MedDRA, special attention into faster data visualization and data quality)

  • Strong track record of leading clinical data management activities; early and late stage, and data standards for submission experience are highly desirable

  • Understanding of FDA and international regulations and GCPs.

  • Fluent in English

  • Spanish desirable but not essential

     

    Skills:

  • Very good communication (oral and written).

  • Strong collaborative skills and ability to work with cross-functional and multi-cultural teams.

     

Application form : CLINICAL DATA LEAD

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Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.
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