Senior Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the planning and implementation of clinical data management activities for global development initiatives.

• Formulate and supervise data management strategies and plans, encompassing the design of data capture tools, data processing, coding, validation, and continuous data quality oversight.

• Establish and sustain clinical data systems and infrastructure.

• Identify, configure, test, and provide technical oversight for EDC, IRT, ePRO, ECG, and various external data-source technologies.

• Propel data standards strategy and compliance throughout the data continuum, including adherence to CDISC/CDASH standards for regulatory submissions.

• Collaborate with internal stakeholders, CROs, and technology vendors on requirements, timelines, deliverables, and performance expectations.

• Oversee vendor technology platforms and processes to ensure regulatory compliance, quality, and inspection readiness.

• Create and manage data management documentation, including data management plans and data transfer plans.

• Manage validated automated data flows for both internal and external data.

• Monitor timelines, milestones, and deliverables; communicate risks, metrics, and status updates to cross-functional teams and leadership.

• Generate and review in-process data reports and listings for trial oversight, safety review, and data review activities.

• Provide data management insights into protocols, protocol amendments, clinical study reports, and statistical analysis plans.

• Ensure data integrity, quality, and regulatory compliance, supporting GCP inspection readiness.

• Contribute to the development of best practices, SOPs, and scalable data management processes for an expanding clinical portfolio.

• Report to the Senior Director of Data Sciences.

⛳️ Requirements

• Bachelor's or Master's degree with at least 6+ years of hands-on clinical data management experience in a pharmaceutical or biotechnology setting.

• Expert knowledge of electronic clinical data systems, including various vendor EDC platforms and associated clinical trial technologies.

• Proven experience in managing and collaborating with CROs and technical vendors, including oversight of deliverables, timelines, and quality.

• Strong comprehension of regulatory requirements affecting clinical data management, with experience in supporting regulatory submissions.

• Experience with Pre-IND, IND, NDA, and/or BLA is highly preferred.

• Demonstrated experience in supporting multiple complex clinical studies, including early-phase first-in-human and proof-of-concept trials.

• Phase I–III experience is preferred.

• Experience in CNS, oncology, and/or rare disease indications is advantageous.

• Exceptional project planning and organizational skills, with the ability to prioritize competing demands, manage timelines, and deliver high-quality work in a fast-paced environment.

• Strong analytical skills, intellectual curiosity, and a proactive problem-solving approach.

• Outstanding interpersonal, communication, and presentation skills, with the ability to influence and collaborate across cross-functional teams and with external partners.

• Strong critical and strategic thinking abilities for analyzing complex data and operational challenges.

• This role is based in the US and may require occasional travel.

🏝️ Benefits

• Company bonus based partly on individual and company performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits including an employee assistance program, fitness benefits, and employee clubs and activities.

• Employee resource groups available to all employees.