Senior Clinical Data Manager

Precision's Data Management team is growing. We are looking for an experienced Senior Clinical Data Manager to join our European team. This position could be covered fully remotely from any of our locations: UK, Spain, Poland, Slovakia, Romania, Hungary or Serbia.

Position Summary:

The Senior 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. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study-specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing.

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

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality, and resourcing.
• Provide input, assess and manage timelines. Ensure that clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
• Train clinical research personnel on the 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 such as external data and EDC vendors in a project manager capacity in support of timelines and data-related deliverables.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.

Qualifications:

• Bachelors and/or a combination of related experience.
• 8+ years’ experience with strong Oncology and/or Orphan Drug therapeutic experience.
• Experience in a clinical, scientific or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).

Other Required:

• Experience in utilizing various clinical database management systems.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Excellent organizational, communication and representational skills.
• Professional use of the English language; both written and oral.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.