Clinical Data Manager II/Senior Clinical Data Manager

Precision Medicine Group

Clinical Data Manager II managing clinical trial data management processes from start to post lock. Overseeing data entry and ensuring quality throughout the data management lifecycle in a global team.

Posted 6/4/2026full-timeRemote • 🇷🇴 RomaniaSeniorWebsite

About the role

Key responsibilities & impact

Responsible and 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 (Lead DM role) for assigned clinical project(s) / program(s)
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
Conduct database build UAT and maintain quality controlled database build documentation
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 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
Coordinate SAE/AE reconciliation
Liaises with third-party vendors
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

Requirements

What you’ll need

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
Ability to undertake occasional travel

Benefits

Comp & perks

Professional development opportunities
Flexible working hours

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial data managementdata entry guidelines developmentquality control of data entrydatabase build UATdata management documentationmedical codingSAE/AE reconciliationdatabase migrationsclinical database management systemsdata management practices

Soft Skills

organizational skillscommunication skillsleadership skillsinterpersonal skillsproblem-solving skillstraining skillsrepresentational skillstime management skillsteam collaborationattention to detail