Full-Time

Sr. Clinical Data Manager

Posted on 5/6/2024

PFM

PFM

501-1,000 employees

Financial advisory and consulting services

Consulting

Senior

Remote in USA

Required Skills
Communications
Management
PowerPoint/Keynote/Slides
Requirements
  • Bachelors and/or a combination of related experience
  • 8+ years’ experience
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
  • Able to handle a variety of clinical research tasks
  • 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
Responsibilities
  • Primary Data Management (DM) contact for assigned clinical project(s) / program(s)
  • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
  • Provide input, assess and manage timelines
  • Develop CRF specifications from the clinical study protocol
  • Conduct database build UAT and maintain quality controlled database build documentation
  • Specify requirements for all edit check types
  • Responsible for creating, revising, appropriate versioning and maintaining data management documentation
  • Train clinical research personnel on study specific CRF, EDC, and other project related items
  • Review and query clinical trial data according to the Data Management Plan
  • Perform line listing data review based on sponsor guidance
  • Run patient and study level status and metric reporting
  • Perform medical coding of medical terms for logic and consistency
  • Coordinate SAE/AE reconciliation
  • Liaise with third-party vendors in a project-manager capacity
  • Identify and troubleshoot operational problems for studies
  • Participate in SOPs and process documentation development
  • Attend strategy meetings, bid defense prep meetings, bid defenses
  • Provide leadership for cross-functional and organization-wide initiatives
  • Train and ensure data management project team members are sufficiently trained
  • Communicate with study sponsors, vendors, and project teams
  • Present software demonstrations/trainings, department/company training sessions
  • May require some travel
  • Perform other duties as assigned

PFM provides financial advisory and consulting services, leveraging Synario and Munite technologies to offer tailored creative consultation and empower clients for sustainable outcomes. The company partners with clients to provide visionaries with the tools for a brighter future.

Company Stage

Grant

Total Funding

N/A

Headquarters

Philadelphia, Pennsylvania

Founded

1975

Growth & Insights
Headcount

6 month growth

0%

1 year growth

1%

2 year growth

-19%
INACTIVE