ABOUT US

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

THE ROLE

We are looking for a Data Manager to join our Biometrics Department where you will will take responsibility for the review of data, both manually or electronically, raising and reviewing queries, performing reconciliation activities with external data whilst setting up and maintaining clinical studies.

You will assist the Senior Data Manager with eCRF design, user acceptance testing, and database lock procedures and as part of the study team will produce study metrics and tracking spreadsheets on a regular basis, providing study updates to the team as required.

KEY ACCOUNTABILITIES

• Communicate issues that may affect the data management of the study to colleagues within the Data Management team.
• Assist with preparation of data management documentation, for example Data Management Plans, eCRF User Guides and Data Transfer Plans and other supportive study documentation.
• Liaise with internal and external suppliers for receipt of electronic data.
• Execute electronic data checks, review results and issues queries via Data Clarification Forms (DCFs).
• Communicate clinical data and quality issues to the Data Management Team Lead and/or manager.
• Test data entry screens for new databases for accuracy and ease of use and document findings.
• Perform quality control of SAS datasets and listings.
• Perform medical coding of clinical data using industry dictionaries.
• Perform reconciliation of electronic 3 rd party data and Serious Adverse Events (SAEs) against the corresponding information within the study database.
• Perform database lock procedures.
• Adhere to agreed study timelines and flag potential problems to the Data Management Team Lead and/or manager.

SKILLS REQUIRED

Essential

• Minimum A levels (or equivalent)
• Previous experience of data management within the pharmaceutical industry or a clinical research organisation
• Experience of working on studies using Electronic Data Capture (EDC) or paper databases
• Experience in study build activities, study conduct and database lock
• Experience in data review and reconciliation activities
• Excellent written and verbal communication skills
• Excellent organisation and time management skills
• Excellent attention to detail, flexible, well-motivated
• Fluent English

Desirable

• A degree or equivalent in any science/maths subject
• Experience with Oracle InForm eCRF
• Experience in SAE reconciliation and medical coding
• Experience of working on oncology and rare disease clinical trials Experience in study build activities, study conduct and database lock

WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.