Senior Clinical Data Manager/Principal Clinical Data Manager

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. 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. 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 (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.
• May support another Lead DM as a back-up and/or team member.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
• May perform quality control of data entry.
• Provide input, assess and manage timelines.
• Ensure that clinical data management deadlines are met with quality.
• Assess resource needs for assigned projects, as needed.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• May assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation.
• Oversee overall quality of the clinical database.
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
• Oversee development of the edit check specifications and manual data review specifications.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
• Oversee completeness of data management documentation for the Trial Master File.
• 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.
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
• Run patient and study level status and metric reporting.
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.
• 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.
• May assist with SAS programming and quality control of SAS programs used in the Data Management department.
• 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.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project.
• Participate 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.
• May review Request for Proposals (RFP), proposals, provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives, where applicable.
• Train and ensure that all data management project team members have been sufficiently trained.
• Communicate 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.
• Perform other duties as assigned.

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.
• 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 presentational skills, ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.
• 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.