Remote opportunity at
pfm medical, inc.Senior Clinical Data Manager
pfm medical, inc. is seeking a Senior Clinical Data Manager to handle all phases of the clinical trial data management lifecycle, from initial study setup through…
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About This Role
pfm medical, inc. is seeking a Senior Clinical Data Manager to handle all phases of the clinical trial data management lifecycle, from initial study setup through post database lock. This role serves as the primary data management contact for assigned projects, overseeing database creation, user acceptance testing, edit checks, and data entry standards. This position involves collaborating with cross-functional teams, managing third-party vendors, coordinating serious adverse event reconciliations, and guiding…
Job Description
pfm medical, inc. is seeking a Senior Clinical Data Manager to handle all phases of the clinical trial data management lifecycle, from initial study setup through post database lock. This role serves as the primary data management contact for assigned projects, overseeing database creation, user acceptance testing, edit checks, and data entry standards.
This position involves collaborating with cross-functional teams, managing third-party vendors, coordinating serious adverse event reconciliations, and guiding medical coding processes. The ideal candidate will provide leadership on departmental initiatives, mentor team members, and ensure that all documentation meets required timelines and regulatory guidelines.
This full-time opportunity is structured as a remote role with an annual salary between USD 133,900 and 200,900, alongside discretionary bonuses and comprehensive benefits including health insurance, retirement plans, parental leave, and paid time off.
Responsibilities
- Serve as the primary data management lead contact for assigned clinical projects
- Oversee the project data entry process, including guidelines, training, quality checks, and resource assessment
- Develop case report form specifications from clinical study protocols and coordinate stakeholder reviews
- Conduct database build user acceptance testing and maintain controlled documentation
- Develop edit check specifications and manual data review specifications
- Maintain complete data management documentation for the Trial Master File
- Train clinical research personnel on study-specific electronic data capture systems and case report forms
- Review and query clinical trial data and perform line listing data review
- Execute medical coding of medical terms to guarantee medical consistency and logic
- Coordinate adverse event and serious adverse event reconciliation
- Collaborate with external data and electronic data capture vendors as a project manager
- Identify and resolve operational bottlenecks using metric data and audit reports
- Participate in creating and maintaining standard operating procedures related to data management
- Provide leadership for organization-wide initiatives and train project team members
Requirements
- 8 or more years of experience working as a Clinical Data Manager
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
- Familiarity with various clinical database management systems
- Broad understanding of effective data management practices alongside drug, device, or biologic development
- Strong oral and written communication skills in English
- Demonstrated leadership and interpersonal capabilities
Qualifications
- Bachelor's degree and/or a combination of related professional experience
- Background in a healthcare, scientific, or clinical discipline
- Familiarity with dictionary medical coding using MedDRA and WHODrug
- Knowledge of CDISC standards such as CDASH, SDTM, and ADaM
- Prior therapeutic experience in oncology and/or orphan drugs
Core Skills
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the source posting explicitly designates this role as remote.
What is the salary range for this job?
The annual salary range is USD 133,900 to 200,900, and the position is also eligible for a discretionary annual bonus and other benefits.
What level of experience is required?
Candidates must have eight or more years of experience working as a Clinical Data Manager.
What benefits are included?
Eligible benefits include health insurance, retirement savings plans, life and disability insurance, parental leave, and paid time off for sick leave and vacation.
Sample Interview Questions
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