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.
- 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.
- 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