Precision Medicine Group
Healthcare
SeniorClinicalDataManager
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“Senior Clinical Data Manager at Precision Medicine Group. Skills: Clinical data management, Database management, Data quality. Manage clinical trial data management process. Oversee database development and testing”
What You'll Achieve.
Ensure data quality; Meet deadlines with quality; Ensure documentation completeness
Industry & Context.
Troubleshoot operational problems
Occasional travel
What They're Looking For.
Must Have
Bachelors and/or related experience, English proficient (Professional level), 8+ years experience, Proficiency in Microsoft Office, Excellent organizational skills, Excellent communication skills, Professional use of English (written and oral), Experience in clinical database management systems, Broad knowledge of drug/device/biologic development, Effective data management practices, Representational skills, Leadership skills, Interpersonal skills
Nice to Have
Experience in clinical, scientific, or healthcare discipline, Dictionary medical coding (MedDRA and WHODrug), Understanding of CDISC standards, Oncology and/or Orphan Drug therapeutic experience
What You'll Do.
Manage clinical trial data management process
Oversee database development and testing
Serve as Primary Data Management contact
Ensure task continuity and responsiveness
Oversee project data entry process
Develop data entry guidelines
Assess and manage timelines
Meet clinical data management deadlines
Assess resource needs
Develop CRF specifications
Coordinate CRF specification review
Assist in building clinical databases
Conduct database build UAT
Maintain database build documentation
Oversee clinical database quality
Specify edit check requirements
Oversee edit check specification development
Create and maintain data management documentation
Oversee data management documentation completeness
Train clinical research personnel
Review and query clinical trial data
Perform line listing data review
Run patient and study level reporting
Perform medical coding
Coordinate SAE/AE reconciliation
Liaise with third-party vendors
Identify and troubleshoot operational problems
Provide feedback on protocols
Participate in SOP development
Maintain process documentation
Attend strategy meetings
Review Request for Proposals (RFP)
Provide project estimates
Provide leadership for initiatives
Train data management team members
Communicate with study sponsors
Communicate with vendors
Communicate with project teams
Present software demonstrations/trainings
Present department/company training sessions
Present at project meetings
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional teams; Project team members; Study sponsors; Vendors; Project teams
Communication Scope
Verbal communication; Written communication; Oral communication
Process & Methodology
Timeline management, Resource assessment, Project estimates
Full Job Description
We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Clinical Data Manager to help build the foundation of our clinical data operations in Mexico. The 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 to 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 Provide input, assesses 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
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