Bdc Study Designer

2 months ago

Maidenhead, United Kingdom Labcorp Full time

**Bedside Data Capture Study Designer - UK, Remote**

Labcorp Drug Development are seeking a **BDC Study Designer** to join our Clinical Pharmacology Services division. This position is fully remote and can be home-based anywhere in the U.K.

The BDC Study Designer is responsible for the creation of studies and all required components within the Bedside Data Capture (BDC) system based on the study protocol and timelines, performing any post go-live updates within the BDC system and working in close conjunction with other BDC staff, Project Managers, Clinic Study Teams, Biometrics, CRAs, IT Staff, and IT Help Desk.

**Your main duties will include but not be restricted to**:

- Effectively configure studies within the electronic data capture system, including recruitment, screening, and on-study components.
- Assignment to complex studies / projects or ownership of a portfolio of studies.
- Perform any post go-live updates within the BDC system
- Understands electronic data capture system and connection to electronic case report form (eCRF).
- Maintains familiarity with routine study procedure forms and becomes familiar with specialized study procedure forms.
- Thoroughly understands system user roles and how they differ.
- Understands general logistics for data collection at the CRU.
- Read and understand study protocols and Labcorp SOPs as background to enable accurate translation of the study design into data collection forms containing both CRF and non-CRF fields within the electronic data capture system.
- Provide feedback on draft protocols from a BDC study setup perspective.
- Communicate and collaborate with internal and external teams to meet study timelines.
- Maintain an understanding of applicable regulatory requirements.
- Provide data and expertise as required to support internal and external requests including audit initiatives.
- Ensure internal standards and client expectations are met or exceeded in terms of quality and timeliness.

**Education/Qualifications**

Minimum Requirements:

- University/College Degree (preferably a Bachelor degree) in a technical or Life Sciences focus area.
- Relevant experience within clinical research environment may be substituted for education requirements.
- Basic understanding of coding logic.
- Strong analytical and interpersonal skills and ability to grasp complex systems, processes, and system improvements with urgency.
- Technical understanding and working knowledge of clinical protocol source data documentation.
- Understanding of simple logic, links code, and algebra.
- Knowledge of end-to-end clinical trial management.

Desirable:

- Experience with IT systems in a CPS environment.
- Experience with:

- Tableau
- MySQL
- JavaScript
- MS Access

**Experience**
- Specific experience working in a clinical research environment with an emphasis in Phase I.
- Understanding of Electronic Data Capture (EDC) and the clinical trial process.
- Experience interpreting Clinical Study Protocols.
- Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
- Strong MS / Office skills in particular with Excel and Word.
- Knowledge of medical terminology preferred.
- Prior experience performing complex technical activities.
- Good computer skills with good working knowledge of a range of software package.

**Desirable**:

- Experience in a regulated (FDA, EPA, etc.) environment.
- Experience with Labcorp CRU operations.

**#LI-Remote, **Remote

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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