Sr. Clinical Data Manager - Remote
Company: Penfield Search Partners
Posted on: May 12, 2022
Job DescriptionContact: Linda Aronova - 646.882.9021 -
firstname.lastname@example.orgJob Description: The Senior Clinical
Data Manager (Sr CDM) is responsible for leading the end-to-end
data management activities and associated quality deliverables for
clinical trials including study set-up, conduct and close-out,
complying with GCP and applicable regulatory guidance. Ensure
activities are completed according to agreed standards and
timelines. Serve as the DM representative in the study team.
Provide comprehensive data management expertise and support to team
members. Coordinate cross functional teams globally to ensure the
flawless conduct of a clinical trial. This includes assuming the
Lead Study Data Manager (L-SDM) role:
- Being accountable for the quality of data management
deliverables and for the delivery of accurate and reliable clinical
study data to ensure the reliability of the study results.
- Representing Clinical Data Management in the Core Trial Team
(CTT). Liaises directly with internal customers (Global Study
Manager, Study Medical Manager, Statistician, Central Monitors,
Pharmacovigilance, Quality, etc.) to coordinate all data management
activities for assigned studies, discuss timelines, and provide
study data management updates. Suggesting solutions for data
management issues that arise during the conduct of a study and
monitor until resolution.
- Planning of all data management activities considering the core
study milestones and ensuring that DM activities are conducted as
- Leading DM activities with internal DM delivery team (Database
Developers, Data Management Programmers, Central Monitors, etc.)
assigned on the study and mentoring new SDMs.
- Accountable for the DM study deliverables, such as CRFs, CRF
Completion Instructions, Centralized Monitoring Plan, Data
Management Plan, Data Validation Specifications, Data Review
- Listings/Reports/Visualizations as per company standards and
- Assuring that data management standards are followed.
- Managing study document archiving in eTMF according to eTMF
- Participating in Investigator Meetings and other outside
meetings if required.
- When necessary, acting as a Study Data Manager contributing to
the delivery of data management activities.
- Maintaining knowledge of current regulations and technologies
related to the data management function.
- Defining and implementing the study data cleaning and
validation strategy integrating risk-based approaches.
- Contributing to the protocol review, Study Risk Management
Plan, SAE reconciliation, deviation review, data review, medical
review, data surveillance and other review activities during the
conduct of a study.
- Coordinating, in collaboration with vendor(s) and internal data
integration experts, all external data activities: loading,
integration activities and reconciliation activities, including
Central Labs, eCOA, IRT, etc.
- Participating in the implementation of department
- Implements and oversees processes and coordinates activities in
conjunction with the internal team and Team Leader. Continually
evaluates DM processes and applications for improvements.
Participates in working groups to develop and implement new
- Ensuring vendor oversight on data management activities while
maintaining a good working relationship with the vendor(s). Reviews
vendor proposal and contract for inclusion of appropriate scope of
work, pricing and agreed services. Performs assessment of vendor
performance trends and service risks. Meets regularly with vendor
representative to implement mitigation actions. Obtains appropriate
approval for scope of work and budget update. Reviews and approves
vendor invoices based on the contract. Ensures all vendor contract
related documents are processed on-time.Formal Education and
- Bachelor's degree or above, preferably in a life science or
mathematics-related area (e.g., computer sciences) and 5+ years of
experience in clinical data management in the pharmaceutical
industry (or equivalent) is required.
- 2+ years of project management experience in data management is
required.Knowledge And Skills:
- Strong data management expertise (i.e., understanding of data
management scope and objectives).
- Strong English skills (both verbal and written).
- Strong project management skills and experience. Anticipate
delivery risks, bottlenecks, issues, and delays to proactively
prevent them or minimize their impact.
Keywords: Penfield Search Partners, Fairfield , Sr. Clinical Data Manager - Remote, Healthcare , Fairfield, Connecticut
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