Manager, Clinical Data

Job Locations US-PA-Wayne
Posted Date 3 months ago(4/8/2021 9:36 AM)
Job ID
2021-1341
# of Openings
1
Category
Clinical

Overview

Position Summary:

The Clinical Data Manager will be responsible for providing comprehensive data management expertise (including all operations tasks and Data Management Plan generation, oversight and approval) while overseeing data management activities to ensure that the Project Team expectations are understood, timelines are met, and quality data delivered.

Responsibilities

Essential Duties and Responsibilities:

  • Manage all aspects of the clinical trial data management process from study start-up to database lock for Aclaris’s clinical trials.
  • Serve as a member of Clinical Study Teams and act as primary Data Management contact and contributor for assigned projects.
  • Oversee CROs, EDC vendors and other third-party vendors in a project manager capacity in support of timelines and data-related deliverables.
  • Monitor timelines and ensures that clinical data management deadlines are met with quality.
  • Perform UAT for database and test according to UAT Plan.
  • Specify requirements for data management documentation, electronic and manual edit checks created by CRO.
  • Review and approve electronic and manual edit checks created by third party vendors.
  • Review and approve data management documentation created and maintained by third party vendors.
  • Ensure that all medical coding is performed on an ongoing basis throughout the life cycle of the program and at the end prior to database lock.
  • Ensure the proper data transfers are conducted (central lab data, ECG data, patient reported outcome data, etc.).
  • Create and maintain electronic and manual edit check specifications for internal studies.
  • Create and maintain data management documentation for internal studies.
  • Oversee the review of clinical trial data to identify erroneous, missing incomplete, or implausible data.
  • Review and provide feedback on protocols.
  • Ensure adherence to data management standards.
  • Provide written and/or verbal status reports to department and project team.
  • Provide data management input to Requests for Proposal.
  • Review vendor proposals, work orders and contracts.
  • Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements.
  • Manage multiple projects.
  • Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, and input from project team members.
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
  • Investigate, evaluate, and implement new technology solutions.
  • Participate in projects / initiatives on request or take on department-wide tasks to contribute to the optimization of processes within the department.

Work Conditions:

  • Due to COVID, employees are required to work remotely but will transition back to a professional office environment.
  • This role routinely uses standard office equipment such as computers, phones, and photocopiers.
  • This position is required to work occasional nights and weekends to meet company demands.
  • Occasional overnight travel to investigator sites or Site Initiation Meetings may be required.

Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Qualifications

Preferred Education and Experience:

  • BA/BS (preferred but not required).
  • Minimum 5-8 years of related experience in clinical data management in the pharmaceutical / biotechnology industry or equivalent.

Required Knowledge, Skills, Abilities & Behaviors:

  • Proficiency with web-based EDC systems experience required.
  • Remote Data Capture (OC/RDC) experience as well as relational database and report development experience, including basic SQL knowledge preferred.
  • Experience with IWRS systems required.
  • Have an understanding of SAS programming.
  • Understand SDTM and ADaM reporting requirements.
  • Strong leadership skills driving change and process by example strategic and critical thinking skills.
  • Demonstrates ability to build and maintain effective relationships with others and establish collaborative partnerships with internal and external stakeholders.
  • Results-oriented; effective ability to set and meet short-term and long-term goals.
  • Strong communication, organization, and decision-making skills.
  • High level of agility and diplomacy.
  • Effective ability to handle matters objectively.
  • Must be able to anticipate challenges and project risks and proactively implement solutions.
  • Strong time management and effective planning skills.
  • Strong working knowledge of MS Office and Outlook.
  • Knowledge and understanding of regulatory guideline for use of computer systems in clinical studies.
  • Demonstrated knowledge of FDA regulations/guidelines, ICH guidelines, GCPs, and computer systems validation.

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