Clinical Data Management Associate II

  • Kite Pharma
  • Uxbridge, UK
  • 10/08/2020
Full time Data Science Data Analytics Big Data Statistics

Job Description

Job Description

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer cell therapy and their translation to the treatment of patients with cancer.

Department Description

We are seeking a highly motivated individual to join us as a Clinical Data Management Associate. You will work with the Biostatistics, Programming, and Clinical Operations teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Manager, Clinical Data Management.

The Clinical Data Management Associate will be responsible for overseeing all aspects of clinical data management for Kite’s clinical development programs with guidance from the Manager, CDM. This position will be responsible for managing CDM vendors, project timelines, clinical data collection, and data review. The Clinical Data Management Associate will also work with Clinical Operations, Safety and Regulatory as necessary

Role Responsibilities:

  • Assist with the review of clinical data on an ongoing basis to ensure quality data
  • Assist with all study start up activities including but not limited to User Acceptance Testing
  • Assist with Study Team line listing review meetings
  • Post queries on behalf of study team members and follow to resolution
  • Run data review reports through BO4 and J-Review
  • Provide study level metrics relating to eCRFs reviewed, Query status, Data Entry and Monitoring Status
  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.

Knowledge, Experience and Skills:

  • Educated to degree level or equivalent
  • Previous experience of working within clinical data management within a pharma/biotech company
  • Oncology experience preferred.
  • Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
  • Experience with Medidata RAVE including study start up, conducting data review and database lock
  • Experience managing clinical data management deliverables for regulatory filings
  • Oncology Data Review Experience
  • Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose