Senior Clinical Data Manager/Principal Clinical Data Manager

Senior Clinical Data Manager/Principal Clinical Data Manager

Remote, United Kingdom

Position Summary:
The Senior Clinical Data Manager/Principal Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post database lock for assigned projects. This position will also oversee and/or perform database development and testing. This is a remote position; candidates can be based in one of the following countries: UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia.

Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact for assigned clinical project(s), ensuring tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, and data entry quality.
• Provide input, assess and manage timelines to ensure clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from stakeholders.
• Conduct database build UAT and maintain quality controlled database build documentation.
• Responsible for creating, revising, and maintaining data management documentation.
• Train clinical research personnel on study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Run patient and study level status and metric reporting.
• Liaise with third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.
• Identify and troubleshoot operational problems for studies based on metrics data and input from team members.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) related to data management activities.
• Provide leadership for cross-functional initiatives, where applicable.
• Communicate with study sponsors, vendors, and project teams regarding data or project issues.
• May require some travel.

Qualifications:
Minimum Required:

• Bachelors and/or a combination of related experience.

Other Required:

• Must have worked as a Lead Data Manager for a Clinical Research Organisation or Pharmaceutical company.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Excellent organizational and communication skills.
• Professional use of the English language; both written and oral.
• Experience in utilizing various clinical database management systems.
• Broad knowledge of drug, device and/or biologic development and effective data management practices.

Preferred:

• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
• Oncology and/or Orphan Drug therapeutic experience.