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Senior Manager, Clinical Data

Company: Novocure Inc
Location: Princeton
Posted on: March 18, 2023

Job 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.


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


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


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.


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



Keywords: Novocure Inc, Trenton , Senior Manager, Clinical Data, Healthcare , Princeton, New Jersey

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