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Manager/Sr. Manager, Clinical Data Management at Crinetics Pharmaceuticals
San Diego, CA, US

Crinetics is seeking a highly motivated Manager/Sr. Manager, Clinical Data Management. This role will be responsible for overseeing the data management function at Crinetics and for managing CRO counterparts. This position will be integral to the development and growth of the clinical development programs. Establishing SOPs to ensure quality data management oversight that complies with industry standards. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the hear of San Diego’s biotechnology community.

Responsibilities:

These may include but are not limited to:

  • Review protocols for proper data capture including Case Report Form design; able to perform a thoroughly detailed review of CRF data requirements
  • Oversee and lead the CRO data management function
  • Create a Data Management Plan that outlines CRF flow, data queries, manual and computer edit checks, and data listings needed to facilitate Data Management activities throughout a clinical study
  • Participate in the design and testing of clinical study databases to match eCRF/CRFs protocol specifications; able to resolve database issues with team members
  • Provide data listings as required
  • Generate data query forms to be resolved at investigational sites
  • Collaborate with CRO partner and cross functional team for Serious Adverse Event reconciliation activities.
  • Provide guidance and monitor the progress of data management activities with CROs or other vendors
  • Present clinical study CRFs and CRF completion instructions at investigator meetings and other trainings as needed
  • Participate in regular team meetings and provide input when appropriate
  • Provide input into the development of data management SOPs and processes; write or review Data Management work instructions and SOPs
  • Interact with CRAs, programmers, study managers and statisticians in overseeing the creation of a clinical study database, perform data quality assurance activities, and manage the resolution of data queries
  • Assist in database upgrades/migrations including performing User Acceptance Tests where appropriate
  • Manage data quality reports
  •  Other duties as assigned

Minimum Qualifications:

  • BA/BS degree preferably in scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered
  • At least 5 years of data management experience required
  • Experience with various EDC systems is desired
  • Service oriented approach, flexible and proactive towards changing needs
  • Working knowledge of current EDC technologies
  • Proficient with the development of eCRF/CRF for clinical trials and its impact on database design/development
  • MedDRA and WHO Drug coding proficiency is desired
  • Excellent verbal and written communication skills
  • Work precisely according to procedures, rules and regulations
  • Must possess a general knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines
  • Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Knowledge of electronic documentation management systems and publishing software a plus

Travel:

Travel may be required up to 20% of your time