Clinical Data Manager/Principal Clinical Data Manager @Precision Medicine Group

[Hiring] Clinical Data Manager/Principal Clinical Data Manager @Precision Medicine Group

Apr 04, 2025 - Precision Medicine Group is hiring a remote Clinical Data Manager/Principal Clinical Data Manager. 💸 Salary: unspecified. 📍Location: UK, Hungary, Poland, Romania, Spain, Serbia, Slovakia.

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Role Description

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.

Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring back-up, continuity, responsiveness, and timely task performance.
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 clinical data management deadlines are met with quality.
Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
May assist in building clinical databases.
Conduct database build UAT and maintain quality controlled database build documentation.
May specify requirements for all edit check types (e.g., electronic, manual data review, edit checks).
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.
Perform line listing data review based on guidance provided by the sponsor and/or Lead DM.
Run patient and study level status and metric reporting.
Perform medical coding of medical terms to ensure medical logic and consistency.
Coordinate SAE/AE reconciliation.
Liaise with third-party vendors such as external data and EDC vendors in a project-manager capacity.
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).
Participate in the development and maintenance of Standard Operating Procedures (SOPs) related to data management and database management activities.
May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and potential client engagement meetings.
May review Request for Proposals (RFP), proposals, and 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 regarding data, database, or other relevant project issues.
May present software demonstrations/trainings, department/company training sessions, and present at project meetings.
May require some travel.
Perform other duties as assigned.

Qualifications

Bachelors and/or a combination of related experience.
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.

Requirements

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.

Company Description

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📍	Be aware of the location restriction for this remote position: UK, Hungary, Poland, Romania, Spain, Serbia, Slovakia
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Clinical Data Manager/Principal Clinical Data Manager @Precision Medicine Group

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Salary 💸 unspecified	Remote Location UK, Hungary, Poland, Romania, Spain, Serbia, Slovakia
Job Type unspecified	Posted Apr 04, 2025

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📍	Be aware of the location restriction for this remote position: UK, Hungary, Poland, Romania, Spain, Serbia, Slovakia
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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