Get Biology JobsGet Biology Jobs

Clinical Data Associate

The Clinical Data Associate Principal position requires a highly skilled individual, who seeks a technical rather than a managerial career path.

Will often be responsible and play a key role in the development, implementation and maintenance of web-based data collection and reporting tools for observational rare disease registries in support of scientific, clinical, regulatory and commercial goals.

Job Responsibilities:

Investigate, evaluate and propose the use of emerging technologies (e.g., electronic data capture) in clinical data management.
Work with the Global Medical Director and project team in designing and developing Case Report Forms (CRFs).
Create the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
Good working knowledge of CDISC-SDTM, ODM, CDASH guidelines.Develop and maintains X-Registry eCRF library and validation checks.
Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing. Lead and assign user accepting testing to data management peers and oversee the completion of the testing.
Execute assigned QC/QA procedures to ensure that clinical databases meet corporate and regulatory standards with accuracy and completeness.
Perform activities related to the implementation, development, maintenance and training of the existing system, e.g. gathering system change requests, incorporating recommendations from users and contributing to system enhancements.
Collaborate with a highly motivated and experienced data management team on process improvement and implementation of new technology.
Participate in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines.
Collaborate with data management peers and other functional departments to define and develop operational type reports to assist with data exploration and metrics for management team.
Develop training materials and provide training on technical applications to data management peers and Site Operations personnel.
Create and manage data management workflow documentation, to include, but not limited to; Data Review Guidelines, eCRF Completion Instructions, Data Validation Plan and Data Management Plan.
Work together with technical vendors and data management team to troubleshoot database bugs/issues from root cause to resolution.
Requires analytical and problem-solving skills, with good attention to detail.
Responsible for tracking individual project tasks and overall project timelines.
Review and approve technical vendor contracts, change orders and invoices.

Skills:

Basic Qualifications:

4-6 years of experience in developing database and validation requirements/specifications
6-8 years of experience with Electronic Data Capture (EDC)
2-4 years of experience with Reporting Tools (e.g., BOXI, SAS, Business Objects)
2-4 years of experience in writing SOPs, Work Instructions, Data Management Plans and Guidelines

Education:

Bachelor's degree in related science/technical discipline required or a minimum of 9 years of data management experience in the Pharmaceutical/Biotechnology industry
Please leave blank
Minimum of 400 (0) characters
Please leave blank
Good news! We have your resume on file, you can use our Quick Apply function to easily apply to this job.

Critical Need Jobs


Employer Information

Previous Page New Search

You're doing a good job! I am always checking out your updated postings. Thanks a lot.

Ronell Seracarpio, Laboratory Assistant

Join 2,655 other Biology Professionals receiving FREE weekly job listings to their inbox every week.

We value your privacy. We will not rent your email to anyone.

Browse other Biology Jobs in Massachusetts

  1. Cell Biologist/Project Leader

    Boston, MA
    US-MA-Boston Job ID 2018-1039 # of Openings 1 Overview Leap Oncology is seeking an independent, highly motivated Cell Biologist to...
  2. Boston Microbiology Tutor Jobs

    Boston, MA
    Boston Microbiology Tutor Jobs.
  3. Biostatistics Operations Manager / Lead...

    Cambridge, MA
    The RWE Biostatistics Operation Manager will be empowered with strategic decision-making responsibility for assigned managed partn...
  4. Equity Research Associate - Biotechnology

    Boston, MA
    Cowen and Company is seeking an Equity Research Associate to work in Boston for its Health Care - Biotechnology team.
  5. Quality Control Analyst

    Cambridge, MA
    ., biology, chemistry, pharmacy) orrelevant field of study and 2 years of experience in an FDA-regulated biotechnology,pharmaceuti...
  6. Scientist: Viral Vector Process Analytical...

    Bedford, MA
    This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a s...
  7. Associate Director/Director of Computational...

    Boston, MA
    US-MA-Boston Job ID 2018-1040 # of Openings 1 Overview Join a dynamic early-stage Boston oncology biotechnology company. ... Inter...
  8. Equity Research Associate - Biotech

    Boston, MA
    Equity Research Associate Biotech. Reports to: Sr.
  9. Clinical Technical Editor

    Boston, MA
    Mercks success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global heal...
  10. Senior RA, Protein Purification

    Waltham, MA
    Our scientific founders are major figures in cancer biology and immunology and have launched Dragonfly to harness the power of the...
Browse all Biology Jobs in Massachusetts
Previous Page New Search