Director, Clinical Data & Systems

Novocure - Portsmouth, NH

Full-time - Senior

Hybrid - Portsmouth, NH

Professional, Scientific, and Technical Services

About the position

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. This role involves liaising with internal and external stakeholders, including Contract Research Organizations (CROs) and data vendors, to ensure study data integrity and the timeliness of key data deliverables. The Director will support Global Clinical Operations in developing solutions that facilitate 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 remote candidates from anywhere in the United States will also be considered. The essential duties and responsibilities include being accountable for CRO oversight of all outsourced Data Management activities and deliverables, as well as managing internal data activities within Global Clinical Operations. The Director will oversee the development and collaboration with internal teams and vendors on all study-level Data Management documents, and will also oversee EDC (and other clinical systems) build and participate in User Acceptance Testing (UAT) for new builds and mid-study updates. As a Subject Matter Expert (SME), the Director will advise study team members, including CRO counterparts and sites, on data capture questions and data-related issues. Additionally, the Director will lead internal data analytics and reporting across multiple systems, participate in study team meetings, and oversee the coordination and facilitation of internal cross-functional data reviews. The role also involves reviewing data metrics, performing trend analyses, and escalating concerns or risks. The Director will manage vendor relationships, provide cross-functional collaboration and communications to enhance data quality and timely data milestones, oversee data imports and merges from multiple systems, and ensure quality by correcting discrepancies. The Director will collaborate on the development and maintenance of dashboards for data analytics, provide ad hoc data and report requests, evaluate Data Management key performance indicators, and develop action plans accordingly. Furthermore, the Director will monitor and improve data collection processes, identify standardization opportunities, and provide recommendations for enriched reporting and data standards. The position requires identifying and communicating lessons learned, best practices, and frequently asked questions, as well as monitoring the budget and scope of work for contracted DM services. The Director will also oversee the tracking of Data Management timelines, ensuring all stakeholders are aware and on target for deliverables, and will support study-specific quality audits and regulatory authority inspections as a SME. Lastly, the Director will assist in training and mentoring other Clinical Operations personnel, providing leadership oversight and motivation, and participate in the implementation of departmental Objectives and Key Results (OKRs).

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.

Requirements

• Bachelor's degree from an accredited college or university, or equivalent work experience, preferably in a related field (Life Science/Computer Science/Statistics).
• 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.
• 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.