Senior Clinical Data Manager REMOTE

Provident Research Inc. (PRI) concentrates on providing Strategic Staffing, Talent Acquisition and FSP solutions to the Pharmaceutical, Biotechnology, Medical Device and CRO industries.

Our Client, a major manufacturer of medical devices (a subsidiary of a major pharmaceutical and healthcare products company) is looking for a full-time (W2) home-based Senior Clinical Data Manager.

This role is responsible for all aspects of clinical data management associated with data cleaning and quality review for assigned projects with minimal supervision.

Will ensure clinical trial data collected meet the highest standards of data integrity, while meeting project timelines, quality issues, resource management and SOW / budgets.

If you have at least 4 years of Clinical Data Management experience in Medical Devices,

Provident Research is looking for you!

This opening is immediate due to expansion.

Benefits :

For the right individuals, this position offers a competitive salary along with :

• Medical, Dental, and Vision
• Disability
• Life Insurance
• 401(k) Plan
• Paid Vacation and Holidays

Education :

A Bachelor’s Degree is required, preferably with strong emphasis in biological sciences, computer science or related discipline, with at least 4 years of clinical data management experience in Medical Device or Pharmaceuticals

Position Duties & Responsibilities :

• Support and supervise several moderate complexity / complex trials
• Create and monitor managers with data management plans and other data management documentations
• Monitor progress and conduct respective projects, including all data cleaning and QC activities to ensure all employees remain on target to project timelines
• Coordinate, facilitate, and participate in all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their prospective projects
• Participate in ongoing data review throughout the conduct of the study, including overseeing the correction of errors and discrepancies management for the life of a project
• Coordinate with Medical Affairs organization to facilitate data coding and safety reviews
• Oversee process improvement, data standards and efficiency gaining initiatives within data management
• Ensure that all clinical data management documentation is stored and archived in timely and compliant manner
• Knowledge of all laws and policies that apply to the job and maintain the highest level of professionalism, ethics, and always in compliance

Functional and Technical Competencies :

• Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.)
• Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software
• Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug)
• Excellent communication, organizational, and data management skills (detailed oriented)
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

PRI is an EEO Employer - Minorities / Females / Protected Veterans / Disabled