Senior Clinical Documentation Specialist

Veristat

Posted on: February 22, 2021

Closing: March 24, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!

Key Purpose: 

The Senior Clinical Documentation Specialist (CDS) provides administrative and technical support for assigned projects during any and all phases of the project (planning, initiation, monitoring, data management and reporting).  S/he must be able to anticipate the needs of a study team and prioritize their workload and schedules to meet these needs.

 

As Senior CDS you will:

  • Assume the role of Super User for assigned clinical system(s); provide support, troubleshooting, training and guidance to end-users
  • Act as a mentor to Clinical Documentation Specialist(s): provide support, training and guidance as needed
  • Contribute to the processes used in the performance of the CDS role, through SOP development and revision, and process improvement.
  • Support the audit and inspection readiness of assigned Trial Master Files (TMFs) by filing/uploading TMF documents in accordance with SOPs, current DIA model and study-specific guidelines, and within designated timelines
  • Contribute to the quality of the TMF by performing quality control checks of the filing/metadata for TMF documents
  • Support the completeness of assigned TMFs through the regular generation of TMF status reports
  • Using a study training matrix, maintain study specific training documentation for internal project team members and escalate non-compliance
  • Process site payments using the Clinical Trial Management System
  • Prepare and distribute agenda and minutes for study team and client technical meetings
  • When needed, participate in user acceptance testing of clinical systems
  • Provide general administrative support including organizing events and special projects, and other miscellaneous duties as assigned.
  • Assist in preparation for sponsor or internal audit and/or regulatory inspections.

 

 Experience & Minimum Requirements:

  • Bachelor’s degree in a relevant field preferred.
  • Minimum of 5 years of experience as a Clinical Documentation Specialist, or equivalent role in a clinical research organization.
  • Expert knowledge of TMF structure/system, essential clinical trial documentation and relevant regulatory standards
  • Highly advanced proficiency in computer skills (Microsoft Word, Excel, Project)
  • Possesses the ability to be flexible and take direction, and a positive attitude
  • Strong interpersonal skills, including helpful attitude and high focus on customer needs; exceptional communication skills
  • Must be detail-orientated, motivated to work in a fast-paced environment, and able to effectively handle confidential matters.
  • Ability to handle multiple tasks and to establish priorities and meet tight deadlines.
  • Ability to process information and propose solutions based on sound reasoning
  • English language proficiency (verbal & written) required.

Veristat

Posted on: February 22, 2021

Closing: March 24, 2021

Salary($): Undisclosed

Position Type: Full Time

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