Senior Clinical Data Manager

Precision For Medicine

Clinical Data Manager II overseeing clinical trial data management from startup to post-lock. Position requires extensive experience in clinical research organizations and related fields.

Posted 6/4/2026full-timeRemote • 🇷🇸 SerbiaSeniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

clinical trial data managementdata entry guidelines developmentquality control of data entryCRF specifications developmentdatabase build UATmedical codingdata management documentationdata reviewdatabase migrationsdata management practices

Soft Skills

organizational skillscommunication skillsleadership skillsinterpersonal skillsproblem-solving skillsrepresentational skillstraining skillstimeline managementcollaboration skillsattention to detail

Tools & Technologies

Microsoft Officeclinical database management systemsEDCSOPsdata management softwarethird-party vendor managementdata entry systemsreporting toolsdata quality toolsproject management tools

Industry Keywords

clinical researchpharmaceuticalbiotechoncologyclinical data managerdata management planSAE/AE reconciliationstudy protocolregulatory compliancebiologic development

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, assess and manage timelines
May develop CRF specifications from the clinical study protocol
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
Liaise with third-party vendors such as external data and EDC vendors
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues

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

Health insurance
401(k) matching
Flexible work hours
Paid time off