This is an (exempt) full-time, home-based position in the USA that will require willingness to work flexible hours as needed to meet business needs.
WHAT YOU WILL DO
In this role, you may independently lead projects or may provide support to the Process Excellence and Delivery team members as needed. As a Clinical Data Strategy & Delivery Lead you may provide project management.
Summary of Responsibilities:
Lead process development, evaluation, and implementation activities or projects, in conjunction with CDSO Process Excellence and Global Development Compliance, for any of the following functions: Clinical Data Operations & Standards, Medical Writing, Testing, Innovation & Data Enablement, and Development Systems & Digital Strategy.
Drive process activities by developing comprehensive project plans, timelines, and communication strategies, ensuring alignment across diverse stakeholders and SMEs.
Lead and support new process and technology implementation across studies, collaborating with study team members.
Identify potential process documentation gaps and collaborate with the CDSO Process Excellence and Delivery team and other functions to propose and implement mitigations.
Lead or support CDSO Process Excellence and Delivery team’s participation in inspection and audit readiness activities.
Lead or support process activities associated with transfer of clinical trial execution activities due to acquisitions and mergers, working with various stakeholders to ensure compliance to processes.
Provide project management support within the CDSO Process Excellence and Delivery team to assist in managing work allocation, project status reporting, team communications, and meeting management.
Foster strong working relationships with cross-functional SMEs and stakeholders to align on strategic objectives, gather expert input, and drive decision-making in a matrix environment.
Support CDSO Business Process Owners (BPOs) by coordinating initiatives, tracking deliverables, and facilitating stakeholder engagement across functional teams.
And all other duties as assigned.
Qualifications (Minimum Required):
Bachelor's Degree or international equivalent required; Life Sciences preferred.
8 or more years’ experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting.
8 or more years of operational experience in project management, process improvement, clinical data management/EDC build and programming, IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience.
Experience (Minimum Required):
Experience in audit and inspection preparation and conduct for clinical data management activities.
PMP or Lean Sigma Six certifications a HUGE PLUS
Experience in managing transfer of clinical data management activities from acquisitions and mergers, including effective collaboration with internal teams and external partners.
SME of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.
Driver of clinical trial technologies, including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.
Excellent teamwork, organizational, interpersonal communication, active listening, conflict resolution and ability to influence without authority across various levels of organization.
Demonstrated matrix leadership and communication skills.
Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.
Global/international experience preferred, including the demonstrated ability to collaborate effectively with team members in other geographic locations.
Applicants must be legally entitled to work in US without the need for employer-sponsored work permits. This position is not eligible for sponsorship.
Work Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
Frequently stationary for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Regular and consistent attendance.
Varied hours may be required.
Pay Range: USD $160,000-170,000
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Flexible time off (FTO).
Application Deadline: 06/12/26
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