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 Clinical Operations. Ideal candidates will be located in the Portsmouth, NH or Chesterbrook, PA Metropolitan areas but we will consider remote candidates anywhere 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
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