pfm medical, inc. is hiring a
Senior Clinical Data Manager in United Kingdom

Summary

The Senior Clinical Data Manager is responsible for managing all aspects of clinical trial data management from start up to post database lock for assigned projects. They oversee project data entry process, develop CRF specifications, conduct database build UAT, manage timelines and resources, and provide input on clinical trial data. They also coordinate with third-party vendors and may assist in SAS programming and quality control of SAS programs.

Requirements

• Bachelors and/or a combination of related experience
• 8+ years’ experience
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
• Able to handle a variety of clinical research tasks
• 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
• Strong representational skills, ability to communicate effectively orally and in writing
• Ability to undertake occasional travel

Responsibilities

• Manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects
• Primary Data Management (DM) contact for assigned clinical project(s)/program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner
• Oversees project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Provides input, assesses and manages timelines. Ensures that clinical data management deadlines are met with quality
• Develops CRF specifications from the clinical study protocol and coordinates the review/feedback from all stakeholders
• May assist in building clinical databases
• Conducts database build UAT and maintains quality controlled database build documentation. Oversees overall quality of the clinical database
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversees development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversees completeness of data management documentation for the Trial Master File
• Trains clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• Reviews and queries clinical trial data according to the Data Management Plan
• Performs line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Runs patient and study level status and metric reporting
• Performs medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinates SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables
• May assist with SAS programming and quality control of SAS programs used in the Data Management department
• Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project
• Participates in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings
• Provides project estimates
• Provides leadership for cross-functional and organization-wide initiatives, where applicable
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicates with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• May present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Performs other duties as assigned

Preferred Qualifications

• 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