clinical operations in south san francisco

posted
job type
contract
salary
US$ 95 per hour
apply now

job details

posted
location
south san francisco, california
job category
Biotechnology & Pharmaceutical
job type
contract
salary
US$ 95 per hour
reference number
25683
apply now

job description

Job Title: Sr. Clinical Data Manager

Position Description

  • As a Senior Clinical Data Manager you will be able to work independently and be accountable to set the priorities and ensure all data management procedures are executed with high attention to detail, accuracy and timeliness. The Senior Clinical Data Manager will work on multi-functional teams and will support CDM through experience and knowledge as a departmental subject matter expert. They will maintain program/project level perspective, focus and communicate effectively as the SME on data management issues, activities, and deliverables.

Position Responsibilities

  • Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements
  • Create, review, and maintain project timelines and monitor progress of data management activities
  • Assist in the preparation and review of specifications for designing, monitoring and transferring of electronic databases
  • Be a strong technical resource relative to CDM and CDM supportive tools, programming and reporting environments
  • Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedure
  • Perform user acceptance testing on database applications and data transfers
  • Create required study documentation (i.e. DMP, DVS and CRF Completion Guidelines)
  • Review and approve CRF design, data review and database design guidelines according to Standard Operating Procedures and protocol specific requirements
  • Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity and accuracy based on project specific guidelines
  • Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
  • Generate and review reports and listings to maintain data integrity and reporting
  • Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers
  • Act as clinical data management liaison/lead to communicate study status, timeline updates, scope change with internal project management and departmental leadership
  • Manage and/or liaise with 3rd party vendors specifically related to data collection, review and analysis, and communicate project timelines
  • Perform external data reconciliation; assist in developing/designing reports and computer programs to assist in the data review process and provide operational metrics
  • Develop strong working relationships and maintain effective communication with Clinical Operations,Safety Regulatory, Biostatistics, Programming, and Quality Assurance
  • Assist in developing data management process and procedure improvements

Position Requirements

  • Bachelors Degree in Life Science, Nursing, Computer Science or related disciplines or equivalent combination of experience and education
  • 8+ years of experience in CDM, of which 3+ years in either a leadership role as a Team Leader/Manager for a significant clinical program, or a supervisorial role within a CDM function
  • Proficiency in the development and use of commercial clinical data management systems/EDC products (e.g. RAVE, Inform, TrialMaster, Oracle Clinical/RDC, etc.)
  • Extensive clinical data management experience in Pharmaceutical or CRO setting
  • Comprehension of medical terminology desirable
  • Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle)
  • Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
  • Clinical Data Mgmt expertise; EDC expertise (experience with Rave is a plus); experience with Data Review tools (i.e. Spotfire, JReview)
  • Flexibility to work remote 1-2 days a week after extablishing themselves

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.