Senior Clinical Data Manager

27 Nov 2024

Vacancy expired!

The Senior Clinical Data Manager Contractor provides technical and operational expertise to the project teams and is responsible for ensuring the data collected meets the requirements of the study objectives for the purpose of clinical study reports, publications, and regulatory submissions. This position will back up a pivotal study and the role may be extended to support multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data. S/he will work within the company’s SOPs, guidelines and standards to ensure data integrity at all times. Specific Responsibilities:

  • Lead CRF design and guidelines for population of CRFs from standards
  • Implementation of CRFs in the database and assuring that the database for each study is live in a timely manner.
  • Must be able to perform end to end clinical data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
  • Work with the CRO and coordinate activities for the medical review of coding data and approval of adverse events, medical history, concomitant and protocol-related medications.
  • Educate study team members by preparing and distributing study related reports, resolving questions and providing clinical data management guidance.
  • Lead interactions between company and outside vendors on the collection, transmittal and transfer of study specific laboratory data.
  • Work collaboratively with DM team members to perform DM tasks for the study
  • Must be able to get up to speed on day to day study activities in a short period of time
  • Must be able to work with multiple deliverables
  • Participate in cross functional team meetings and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to Clinical Operations.
  • Work closely with safety, clinical operations group, biostatisticians, SAS programmers and other staff as appropriate to develop CRFs to ensure the required information is captured for statistical analysis.
  • Work with biostatisticians and SAS programmers to harmonize data collection, compile and maintain SAS data standards.
  • Provide review and oversight on quality database design, validation, and deployment to ensure quality and efficiencies through data and process standardization.
  • Review clinical study protocols and statistical analysis plans and ensure data quality for data analyses.
  • Take a leadership role in the review and query of clinical data. This includes participation of the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock.
  • Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines.
  • Assist in addresses Regulatory Submission issues within Biometrics and with other related departments.
  • Utilize appropriate CDM concepts and resources to solve moderately complex technical CDM issues.
  • Lead initiatives to gather, organize, and analyze interim clinical data from various data sources, and examines issues from various perspectives.
Additional Functions and Responsibilities:
  • Serve as a technical resource to colleagues; troubleshoot technical problems.
  • Coordinate the transfer of clinical data between all vendors participating in a clinical study.
  • Assist in design of case report forms (CRFs) for clinical studies.
  • Assist in the compilation of clinical data for regulatory submissions
  • Other duties as assigned.
Qualifications:
  • 7+ years of CDM experience
  • Excellent verbal and written communication skills and strong interpersonal skills are required.
  • Oncology experience is mandatory
  • Experience with Electronic Data Capture (EDC) and experience with Rave is a must
  • Experience managing Clinical Research Organizations (CROs)

  • ID: #23548803
  • State: California Sancarlos 94070 Sancarlos USA
  • City: Sancarlos
  • Salary: $54 - $55
  • Job type: Contract
  • Showed: 2021-11-27
  • Deadline: 2022-01-14
  • Category: Et cetera