Clinical Data Management Specialist

San Diego, CA, US
Oct 31, 2020
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Position Summary

The Clinical Data Management Specialist position is responsible for the assisting in the technical and administrative functions associated with a clinical trial. The primary responsibilities include aiding in EDC set-up, study database design, data discrepancy management, data review, project support, and study document management. The position will perform duties in compliance with the protocol, data standards, and SOPs

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Data cleaning, aid in database build, query management, document preparation and management
  • Assist in the design of CRFs, CRF completion guidelines, and data handling conventions; assist in review of edit check specifications, and data management plan.
  • EDC database review and quality control (visit structure, edit checks, implementation or randomization scheme, compliance with the protocol)
  • Perform user acceptance testing (UAT) for clinical trial databases.
  • Review of EDC data for completeness and correctness, querying of sites for problems, issues, or trends and escalation within Clinical Development as necessary. Reconciliation of external data (such as laboratory data, serious adverse events/events of interest information, or, if needed, independent review by medical personnel) with EDC data
  • Use or implement data views for optimal and efficient review of large quantities of data
  • Review of CDISC SDTM conformance reports to understand data conformance issues that need Data Management action
  • Collaborate with Pharmacovigilance department to perform serious adverse events reconciliation and medical coding
  • Oversee medical coding activities
  • Support the effective management of CROs and other external vendors
  • Provide other support to Clinical or Biostatistics and Data Sciences departments, as needed.
  • Reads protocols to learn about data collection, database and reporting requirements and standards. Ensure data management documentation is appropriated filed in the electronic trial master files
  • Development of external data specifications (such as laboratory or EKG data specifications)
  • Conduct audits of the clinical database against CRFs and other source documents, as necessary (paper CRFs only)
  • Participate in development of internal documentation and infrastructure such as SOPs and data management documents templates to support in-house Data Management activities
  • Provide progress reports of activities to lead data managers
  • Interact with clinical study team members to resolve database issues and report on the progress of CDM activities

Minimum Education, Experience and Skills

  • Bachelor's degree in statistics, mathematics, computer science, biology or related scientific field. High School diploma possible but would be career path limiting.
  • At least 3 years of relevant data management experience in a pharmaceutical, biotech, CRO or other clinical research setting. CCDM certification preferred.
  • Hands-on experience and exposure to CDISC standards, including CDASH, SDTM controlled terminologies, aCRF, cSDRG, and define.
  • Experience in management of clinical data and associated documentation needed to meet regulatory and company standards.
  • Experience using EDC systems to manage clinical data
  • Experience with all stages of CDM from study start-up to study close; familiar with multiple phases of clinical development.
  • Experience with developing study documents, particularly CRFs, edit check specifications, and DMPs
  • Working knowledge of GCP, ICH, FDA and HIPAA regulations and guidelines.
  • Exposure to hands on database development a plus
  • Experience with IXRS, ePRO/eDiary, medical coding, and SAE reconciliation preferred.
  • Experience with additional statistical software such as SAS, R and JMP is a plus.
  • Flexible, adapts work style to meet organizational needs. Ability to work proactively and effectively in a fast paced, high change environment.
  • Ability to work collaboratively in a team
  • Effective communicator, both oral and written. Demonstrated ability to communicate with non-data focused people is a must.
  • Excellent organizational skills and ability to prioritize tasks, with mentorship
  • Excellent computer skills and proficient in the used of Adobe Acrobat and Microsoft Office products.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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