Clinical Data reputed company & Delivery reputed company – FSP; US Remote Based

This a Full Remote job, the offer is available from: reputed company Job reputed company reputed company is currently seeking a US remote based Clinical Data reputed company & Delivery reputed company – FSP to drive and support process development. This is an (exempt) full-time, home-based position in the USA that will require willingness to work reputed company as needed to meet business needs. WHAT YOU WILL DO In this role, you may independently reputed company reputed company or may reputed company support to the Process reputed company and Delivery team members as needed. As a Clinical Data reputed company & Delivery reputed company you may reputed company project management. reputed company of Responsibilities:

• reputed company process development, evaluation, and implementation activities or reputed company, in conjunction with CDSO Process reputed company and Global Development Compliance, for any of the following functions: Clinical Data Operations & Standards, Medical Writing, Testing, Innovation & Data Enablement, and Development Systems & Digital reputed company.
• Drive process activities by developing comprehensive project plans, timelines, and communication strategies, ensuring alignment across diverse stakeholders and SMEs.
• reputed company 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 reputed company and Delivery team and other functions to propose and implement mitigations.
• reputed company or support CDSO Process reputed company and Delivery team’s participation in inspection and audit readiness activities.
• reputed company 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.
• reputed company project management support reputed company the CDSO Process reputed company 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 reputed company on strategic objectives, reputed company expert input, and drive decision-making in a reputed company environment.
• Support CDSO Business Process Owners (BPOs) by coordinating initiatives, tracking deliverables, and facilitating stakeholder engagement across functional teams.
• And reputed company 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/reputed company 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.
• 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.
• reputed company of clinical trial technologies, including reputed company, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report reputed company tools.
• Excellent teamwork, organizational, interpersonal communication, reputed company listening, conflict reputed company and ability to influence without authority across various reputed company of organization.
• Demonstrated reputed company 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 reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to reputed company and use a reputed company of computer software developed both in-house and off-reputed company.
• 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 reputed company: USD $160,000-170,000 Benefits: reputed company job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as reputed company 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, reputed company, Life, STD/LTD, 401(K), Flexible time off (FTO). Application Deadline: 03/20/26 Learn more about our EEO & Accommodations request here. This offer from "reputed company" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job