Remote opportunity at
pfm medical, inc.Clinical Data Manager II
pfm medical, inc. is hiring a remote Clinical Data Management II professional on a full-time basis. This role suits someone experienced in overseeing clinical trial data…
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About This Role
pfm medical, inc. is hiring a remote Clinical Data Management II professional on a full-time basis. This role suits someone experienced in overseeing clinical trial data management processes from initiation through post database lock. Under supervision, the selected candidate acts as the primary data contact or contributor for assigned projects, guiding database builds, user acceptance testing, and documentation completeness in alignment with standard operating procedures and regulatory standards. The position…
Job Description
pfm medical, inc. is hiring a remote Clinical Data Management II professional on a full-time basis. This role suits someone experienced in overseeing clinical trial data management processes from initiation through post database lock. Under supervision, the selected candidate acts as the primary data contact or contributor for assigned projects, guiding database builds, user acceptance testing, and documentation completeness in alignment with standard operating procedures and regulatory standards.
The position involves collaborating with third-party vendors, designing case report form specifications from protocols, managing edit check requirements, and coordinating serious adverse event reconciliations. Responsibilities also include training research staff on electronic data capture systems, reviewing clinical trial data, handling medical coding, and providing metric reporting. Additionally, the individual may assist with SAS programming, participate in proposal reviews and strategy meetings, and contribute to standard operating procedures and process documentation. Occasional travel may be necessary.
Responsibilities
- Serve as the primary data management contact or contributor for assigned clinical projects
- Develop case report form specifications from protocols and coordinate stakeholder feedback
- Build clinical databases, conduct user acceptance testing, and maintain documentation
- Create and maintain data management documentation and Trial Master File completeness
- Train clinical research personnel on study-specific case report forms and electronic data capture systems
- Review and query clinical trial data, perform line listing data reviews, and handle medical coding
- Coordinate serious adverse event and adverse event reconciliation
- Liaise with third-party vendors to support project timelines and deliverables
- Identify and troubleshoot operational issues based on metrics, audits, and team input
- Communicate with sponsors, vendors, and project teams regarding project issues
Requirements
- At least 5 years of clinical data management experience or demonstrated aptitude in key role skills
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
- Experience utilizing a clinical database management system
- Broad knowledge of drug, device, or biologic development and effective data management practices
- Fluent reading, writing, speaking, and comprehension of the English language
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor's degree and/or a combination of related experience
- Understanding of dictionary medical coding such as MedDRA and WHODrug
- Understanding of CDISC standards including CDASH, SDTM, and ADaM
- Oncology therapeutic experience
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 posting lists the role and remote status as remote.
What is the salary range for the Clinical Data Manager II role?
The compensation range is between USD 110,700 and 166,100 per year, and the role is eligible for a discretionary annual bonus alongside other benefits.
What level of experience is required?
Candidates must have at least five years of clinical data management experience or a demonstrated aptitude in the key skills for the role, along with a bachelor's degree or a combination of related experience.
Does the posting mention any travel requirements?
Yes, the posting indicates that the position may require some travel.
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