Precision for Medicine
ClinicalDataManagerII/SeniorClinicalDataManager
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“Clinical Data Manager II/Senior Clinical Data Manager at Precision for Medicine. Skills: Clinical data management, Database management, Data quality control. Manage clinical trial data management process. Oversee database development and testing”
What You'll Achieve.
Ensure deadlines are met with quality
Industry & Context.
Troubleshoot operational problems; Identify issues; Identify obstacles; Identify barriers
Occasional travel
What They're Looking For.
Must Have
Bachelors and/or related experience, 8+ years Sr. Clinical Data Manager, 5 years Clinical Data Manager II, Proficiency in Microsoft Office, Handle clinical research tasks, Organizational and communication skills, Professional English (written and oral), Utilize clinical database systems, Broad knowledge of drug/device/biologic development, Effective data management practices, Representational skills, Communicate effectively orally and in writing, Leadership and interpersonal skills, Undertake occasional travel
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
Support Lead DM as back-up
Oversee project data entry process
Develop data entry guidelines
Manage data entry quality
Assess resource needs for projects
Develop CRF specifications
Coordinate CRF review/feedback
Assist in building clinical databases
Conduct database build UAT
Maintain quality controlled database build documentation
Oversee clinical database quality
Specify edit check requirements
Oversee edit check specification development
Oversee manual data review specification development
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 status reporting
Perform medical coding of medical terms
Ensure medical logic and consistency
Coordinate SAE/AE reconciliation
Liaise with third-party vendors
Support vendor timelines and data deliverables
Assist in reviewing protocols
Assist in reviewing SAP
Assist in reviewing CSR
Participate in SOP development
Participate in process documentation maintenance
Attend strategy meetings
Attend bid defense prep meetings
Attend capability presentations
Attend potential client engagement meetings
Review Request for Proposals (RFP)
Provide project estimates
Provide leadership for initiatives
Train data management project 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 initiatives; Project team members; Study sponsors; Vendors; Project teams
Communication Scope
Oral communication; Written communication; Presentations
Process & Methodology
Project management, Timeline management, Resource needs assessment
Full Job Description
*This position is 100% remote, but the preference is to have someone on the east coast* Position Summary: 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 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. 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 on the study specific CRF, EDC, and other project related
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