Director, Clinical Data & Systems
Company: Novocure Inc
Location: Princeton
Posted on: September 12, 2024
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Job Description:
Description:
The Director, Clinical Data and Systems is responsible for
overseeing Data Management services from clinical study initiation
through closure, for the Global Clinical Operations portfolio of
studies, in accordance with applicable Standard Operating
Procedures (SOPs), federal and local regulations, and ICH-GCP
guidelines.
The Director liaises with internal and external stakeholders,
including Contract Research Organizations (CROs) and data vendors,
ensuring study data integrity and timeliness of key data
deliverables.The Director will support Global Clinical Operations
in developing solutions that support data-driven decision
making.This is a full-time, remote based position reporting to the
Head of Global Clincal Operations. Ideal candidates will be located
in the Portsmouth, NH or Chesterbrook, PA Metropolitan areas but we
will consider remote candidates anyhwere in the United States of
America.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Accountable for CRO oversight of all outsourced Data Management
activities and deliverables and management of internal data
activities within Global Clinical Operations
Oversee the development and collaboration with internal teams and
vendors on all study-level Data Management documents
Oversee EDC (and other clinical systems) build and participate in
User Acceptance Testing (UAT) for new builds and mid-study
updates
Advise, as a Subject Matter Expert (SME), study team members,
including CRO counterparts, and sites on data capture questions and
data-related issues
Lead internal data analytics and reporting across multiple
systems
Participate in study team meetings (internal and external)
Oversee the coordination and facilitation of internal
cross-functional data reviews
Review data metrics, perform trend analyses, and escalate
concerns/risks
Perform vendor management (e.g. CRO, Labs, Imaging vendors)
Provide cross-functional collaboration and communications to
increase data quality and timely data milestones
Oversee data imports and merges from multiple systems, correct
discrepancies, and ensure quality
Collaborate on the development and maintenance of dashboards to
provide data analytics
Provide ad hoc data and report requests in connection with normal
business operations, audit requests, and legal and regulatory
requirements
Evaluate Data Management key performance indicators and develop
action/escalation plans accordingly
Monitor and improve data collection processes; partner to identify
how to standardize data across multiple systems; provide
recommendations for enriched reporting and data standards
Identify and communicate lessons learned, best practices and
frequently asked questions
Monitor budget and scope of work for contracted DM services;
collaborate with study team and vendors to review DM out of scope
costs
Oversee the tracking of Data Management timelines, ensuring that
all applicable stakeholders are aware and on target for
deliverables, including EDC go-live, mid-study system updates,
interim data snapshots, and database locks
Identify and escalate project and quality issues; supports
corrective/preventive actions as required
Support study-specific quality audits and regulatory authority
inspections, acting as a SME
Assist in training and mentoring of other Clinical Operations
personnel, providing leadership oversight and motivation
Participate in the implementation of departmental Objectives and
Key Results (OKRs); recommend process improvements and initiatives
to enhance operations
Other related duties, as assigned
QUALIFICATIONS/KNOWLEDGE:
Bachelor's degree from an accredited college or university, or
equivalent work experience, preferably in a related field (Life
Science/Computer Science/Statistics), required
Minimum of 10 years relevant experience in clinical research Data
Management
Lead data manager experience required
Solid tumor oncology experience required
Global trial experience required
Personnel management experience required
Knowledge:
Working knowledge of the pharmaceutical/device commercialization
process, applicable standards, and regulatory guidelines (ISO,
ICH-GCP, MDR etc.)
Expert understanding of global data operations tasks, specifically
within Data Management and database programming and relevant data
standards
Demonstrated technical experience with EDC and other data systems,
preferably Medidata systems
Expert understanding of relational databases and data capture
standards (e.g. CDASH)
Advanced computer skills, including proficiency in MS Office (Word,
PowerPoint, Outlook, Excel); including with complex pivot tables
and data analysis
Strong ability to identify and resolve complex challenges using
critical thinking skills
Excellent organizational and record-keeping skills with strong
attention to detail, precision, and accuracy
Advanced ability to manage and prioritize multiple tasks
simultaneously, proactively problem-solve, and manage competing
priorities and deadlines
Demonstrated ability to work well in a team as well as
independently with limited oversight; is self-motivated and
results-driven
Excellent verbal and written communication skills, providing clear,
concise, timely, and relevant information
Advanced vendor and relationship management skills (i.e. CROs,
central laboratories, other contractors)
Demonstrated ability to analyze related budgets and assess Data
Management costs
OTHER:
Ability to lift up to 20 pounds (9 kg)
Ability to travel up to 20%, both domestically and
internationally
Fluent in English; excellent English verbal and written
communication skills
Equal Opportunity Employer, including disability/veterans.
ABOUT NOVOCURE:
Our vision
Patient-forward: aspiring to make a difference in cancer.
Our patient-forward mission
Together with our patients, we strive to extend survival in some of
the most aggressive forms of cancer by developing and
commercializing our innovative therapy.
Our patient-forward values
- innovation
- focus
- drive
- courage
- trust
- empathy
#LI-REMOTE
#LI-BH1
Keywords: Novocure Inc, Trenton , Director, Clinical Data & Systems, Executive , Princeton, New Jersey
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