Senior Manager, Clinical Data
Company: Novocure Inc
Location: Princeton
Posted on: March 18, 2023
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Job Description:
Description:
The Senior Manager, Clinical Data is responsible for overseeing
program-level Data Management services from clinical study
initiation through closure, in accordance with applicable Standard
Operating Procedures (SOPs), federal and local regulations, and
ICH-GCP guidelines.
The Senior Manager 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 Senior Manager 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
Associate Director, Clinical Data Liaison.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Lead CRO oversight of all outsourced Data Management activities and
deliverables
Develop/collaborate with internal teams and vendors on all
study-level Data Management documents
Drive EDC (and other clinical systems) build and participate in
User Acceptance Testing (UAT) for new builds and mid-study
updates
Advise study team members, including CRO counterparts, and sites on
data capture questions and data-related issues
Participate in study team meetings (internal and external)
Coordinate and facilitate 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
Assist or 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
Track Data Management timelines and ensure 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 Subject Matter Expert (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 8 years relevant experience in clinical research Data
Management
Lead data manager experience required
Solid tumor oncology experience preferred
Global trial experience required
Personnel management experience required
Working knowledge of the pharmaceutical/device commercialization
process, applicable standards, and regulatory guidelines (ISO,
ICH-GCP, MDR etc.)
Advanced understanding of global data operations tasks,
specifically within Data Management and database programming and
relevant data standards
Strong technical experience with EDC and other data systems,
preferably Medidata systems
Intermediate 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
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
Strong ability to manage and prioritize multiple tasks
simultaneously, proactively problem-solve, and manage competing
priorities and deadlines
Strong 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
Strong vendor and relationship management skills (i.e. CROs,
central laboratories, other contractors)
Ability to analyze related budgets and assess Data Management
costs
OTHER:
Ability to travel up to 20%, both domestically and
internationally
Fluent in English; excellent English verbal and written
communication skills
Novocure is taking a responsible approach to creating environments
that allow us to strive to extend survival in some of the most
aggressive forms of cancer by developing and commercializing our
innovative therapy.
As part of our commitment to health and safety COVID-19 vaccines
are required for our current U.S. employees.As an Equal Opportunity
Employer and it is our policy to provide reasonable accommodations
to any qualified individual who because of a medical condition or
sincerely held religious belief or practice receives an exemption
from the vaccination requirement, provided that such accommodation
would not result in an undue hardship for the company. For more
information regarding the Novocure's COVID vaccination requirement,
exemptions, and verification of vaccination status please ask the
Talent Acquisition team.
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-KJ1
#LI-REMOTE
Keywords: Novocure Inc, Trenton , Senior Manager, Clinical Data, Healthcare , Princeton, New Jersey
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