Clinical Data Manager II

Precision For Medicine; Polska; À distance; GBP 65 000 - 90 000; Plein temps

Résumé du poste

Precision For Medicine in the United Kingdom is seeking a Clinical Data Manager II or Senior to join our global team. The role covers data management from start-up to database lock and may oversee database development and testing.

You will act as lead DM, develop data entry guidelines, ensure timelines, review protocols, and liaise with sponsors and vendors. Oncology experience and strong communication are valued; travel may be required.

Qualifications

• Bachelor’s degree or higher in life sciences or related field; combination of related experience acceptable.
• 8+ years’ experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II in CRO/biotech/pharma settings.
• Experience with data migrations and database setup from protocol.
• Oncology experience preferred; proficiency with MS Office suite.

Responsabilités

• Serve as Primary Data Management contact for assigned projects, ensuring back-up coverage and timely task execution.
• Oversee data entry processes, develop guidelines, train staff, and ensure data quality and resource planning.
• May perform data entry quality control and review CRF specifications from study protocols.
• Lead database build UAT and maintain documentation for trial databases.
• Coordinate edit checks specifications and manual data review.
• Maintain Trial Master File data management documentation and version control.
• Train staff on study CRF, EDC, and project items as needed.
• Communicate with sponsors, vendors, and project teams on data issues.

Connaissances

Clinical data management

Leadership

Communication

English proficiency

Project coordination

Formation

Bachelor’s degree or higher in life sciences or related field

Outils

Microsoft Office

CDMS software

SAS programming (basic)

Description du poste

We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team. We can consider candidates based in the Poland, Hungary, Romania, Serbia or Slovakia.

Position Summary:

The Clinical Data Manager II/Senior Clinical Data Manager is responsible and manages 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. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs.
• 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, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed.
• May 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.
• 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
• 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
• 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
• Trains and ensures 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:

• Bachelors and/or a combination of related experience
• 8+ years’ experience as a Sr. Clinical Data Manager or 5+ Years as a Clinical Data Manager II working for a Clinical Research Organisation, Pharmaceutical or Biotech company
• Set up and Database migrations experience
• Oncology experience preferred
• 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
• Strong representational skills, ability to communicate effectively orally and in writing
• Strong leadership and interpersonal skills