Clinical Data Manager/Senior Clinical Data Manager

Theradex Systems, Inc.; United Kingdom; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A global clinical research organization is hiring a Clinical Data Manager/Senior Clinical Data Manager in the UK. This hybrid position involves managing oncology trials, collaborating with various teams, and ensuring compliance with regulatory standards. The ideal candidate will have a bachelor's degree, extensive data management experience in the CRO/pharmaceutical sector, and strong skills in programming and GCPs. A supportive culture and competitive benefits are offered.

Benefits

6% pension contribution

Private medical insurance

Sick pay

Income protection insurance

Life assurance

Eyecare voucher scheme

Employee assistance program

Qualifications

• 3-5 years relevant data management experience in CRO/pharmaceutical industry.
• EDC experience required, RAVE EDC experience preferred.
• Strong understanding of CDISC CDASH and SDTM Standards.

Responsibilities

• Perform Clinical Data Management activities in compliance with SOPs.
• Work with SAS Programming and Biostatistics teams.
• Lead clinical data manager on studies with minimal supervision.

Skills

Knowledge of GCPs

Effective problem anticipation

Excellent interpersonal skills

Fluent English

Proficient in Word and Excel

Strong communication skills

Time management

Education

Bachelor’s degree required / Master’s degree preferred

Tools

RAVE EDC

SQL/SAS programming

Job description

Who We Are

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service based company we support both domestic and international sponsors in the conduct of both early and late phase trials. As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will the work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

What You'll Do

We are hiring a Clinical Data Manager/Senior Clinical Data Manager based in the UK.

This is Hybrid position with a minimum of 1 day in the Crawley, West Sussex office. Candidates ideally located close to Gatwick Airport and London area, with excellent motorway and rail connections for travel to the office.

The primary responsibilities of this position include, but are not limited to, the following:

• Perform all Clinical Data Management activities in compliance with SOPs and ICH-GCP regulatory requirement
• Work closely and collaboratively with the SAS Programming team, Biostatistics team and other Data Managers
• Act as lead clinical data manager on multiple studies of moderate complexity with minimal supervision
• Serves as the main point of contact for study DM related matters
• Lead DM Study Start-Up Activities
• Conduct EDC User Acceptance Testing and program validations.
• Develop programs in SAS/EXCEL for study data metrics monitoring and clinical data review.
• Perform comprehensive data review of all patient data.
• Perform WHO Drug Dictionary coding and MedDRA coding as necessary
• Support Project Team through:
  • Tracking and provision of project status updates to project managers for monthly project team meetings
  • Close communication with CRA’s to identify and mitigate negative data trends/issues
  • Provision of listings/reports as needed
  • Create ad-hoc reports for special data requests from Sponsor
  • Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
  • Coordinate all activities in preparation for study milestones and database lock
• May assist in the mentoring of less experienced employees
• Manage and prioritize project deliverables per established study timelines

What You Need

Level of Education and Prior Experience

• Bachelor’s degree required / Master’s degree preferred
• 3-5 Years relevant data management experience in the CRO / pharmaceutical industry required
• EDC experience required, RAVE EDC experience preferred
• SQL/SAS programming experience preferred

Skills and Competencies

Demonstrates knowledge of GCPs and protocolStrong understanding of CDISC CDASH and SDTM StandardsHighly effective ability to anticipate problems relating to projects and to develop and implement solutionsExcellent interpersonal skillsFluent knowledge of written and verbal EnglishHighly organized and result-orientedStrong communication, comprehension and logic skillsAbility to work independently with minimal supervision as well as in a team environmentProficient in Word and ExcelAbility to understand high level programming languagesStrong time management and prioritization skills to meet deadlines among multiple projects

What we offer:

We offer a friendly and supportive culture that puts people first. We provide a competitive compensation and benefits package including 6% pension contribution, private medical insurance, sick pay and income protection insurance, life assurance , eyecare voucher scheme and employee assistance program.

Theradexis an equal opportunity employer. All qualified applicants are encouragedto apply and will receive consideration for employment.

This job does not offer company sponsorship.