Biotech/Pharmaceutical

Senior Clinical Data Manager – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

No 3rd Party Agencies

Job Description: The Clinical Data Manager manages all aspects of the clinical trial data management process from study start up to post database lock for assigned studies.  Serves as a key contributor to the success of the Data Management team.  Oversee multiple large and complex studies, performing and delegating tasks as appropriate. Effectively interact with sponsors and manage vendors. 

Responsibilities:

  • Primary Data Management contact and/or contributor for assigned clinical projects, ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
  • Provide input into timelines. Ensure that clinical data management deadlines are met with quality.
  • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
  • Conduct database build UAT and maintain quality controlled database build documentation.
  • Specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
  • Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming.
  • Coordinate with vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation.
  • Troubleshoot technical issues as appropriate.
  • Perform SAE/AE reconciliation.
  • Perform pre-lock and data lock tasks.
  • Participate in vendor and internal meetings as required, providing status updates and advising on best practices as appropriate.

Requirements:

  • BS in a clinical or scientific discipline with 9+ years direct clinical data management experience in a pharmaceutical, academic, or CRO environment.
  • The successful candidate will be an agile thinking and collaborative individual with both a strong track record of hands-on clinical data management experience and leadership capabilities.
  • Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
  • Excellent organizational and time management skills
  • Strong collaboration and leadership skills
  • Working knowledge of industry standards, such as CDISC/SDTM
  • Basic understanding of SAS, SQL and/or other clinical programming
  • Understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug
  • Good working knowledge of GCP and ICH guidelines, and Good Clinical DM practices
  • Plans, schedules, and monitors work to meet time and quality targets.
  • Ability to absorb, translate and communicate complex matters.
  • Excellent written and verbal communication
  • Must be able to interact and liaison effectively with people at all levels of the organization and with external vendors, investigators, site personnel, etc.

Tagged as: Senior Clinical Data Manager - Remote