Lead Clinical Data Manager Remote Job Opening at Somerset, New Jersey, USA, Bevov

Lead Clinical Data Manager - Remote

Somerset, NJ

Experience

5 to 7 (Yrs)

Salary

130000-165000 per Year

Skillset

CDM ECRF CDISC CDASH SDTM Medidata RAVE ICH CRO Oracle InForm Gcp

Location

Somerset, NJ

Job Type

Contract

Remote

Yes

Job Description

We are currently recruiting a full-time, remote-based Lead Clinical Data Manager (consultant to potential permanent) experienced in all CDM start-up, maintenance, and closeout activities to coordinate/lead and perform day-to-day Data Management activities. This role will be client-facing. The LDM will be responsible for ensuring all DM activities are met in a timeline manner and with excellent quality. The LDM works closely with the DM program manager to ensure end-to-end Data Management coverage of all assigned studies and consistency across the study program. Hours are flexible with core hours of 9:30 am -3:30 pm Eastern.

Responsibilities

  • Serve as the client’s point of contact (POC) for all DM activities
  • Serve as project leader for internal team members
  • Perform project management activities such as
    • Project Timeline creation
    • Coordinate internal staff activities
    • Ability to communicate and escalate appropriately to internal management and client appropriately.
  • Review protocol and attend protocol review meetings or provide feedback, as needed.  
  • Coordinate eCRF specifications according to the protocol.
  • Assist in the design and review of study databases.
  • Author or review eCRF completion guidelines.
  • Develop or lead the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, data review and query handling, coding, SAE reconciliation, external data reconciliations, reports, data lock, and archiving, etc.
  • Develop or lead the review of edit check specifications, as well as perform/coordinate UAT.
  • Provide study metrics and status reports to internal and/or client teams.
  • Provide updates to team questions on program tasks and scope.
  • Perform or lead data cleaning activities.
  • Perform or lead SAE reconciliation activities.
  • Perform or lead external data reconciliation activities.
  • Perform or lead database lock and freeze activities.
  • Assist or generate study timelines.
  • Ensure approved study documents are maintained and properly stored in the trial master file.

Qualifications

  • BS/BA degree or equivalent with a minimum of 5-7 years of experience in a pharmaceutical/CRO setting
  • Minimum of 2 years in a client-facing role leading a study
  • Advanced knowledge of Clinical Data Management process and challenges 
  • Proficient knowledge of CDISC CDASH and SDTM terminology
  • Has been involved in at least two different types of phases
  • Has been involved in 2 different indications
  • Proficient knowledge of Medidata RAVE, Oracle InForm, and/or IBM Clinical Development
  • Comprehension of the principles of quality, safety, risk management, and compliance (ICH and GCP).
  • Excellent verbal and written communication and problem-solving skills
  • Flexible, self-starter who thrives independently, as well as in collaboration with other Clinical Trial professionals in a Global environment