GLOBAL PROJECT SPECIALIST

RESPONSIBILITIES

- Provide day to day oversight and support in conjunction with Project Managers (PM) in the planning and execution of imaging clinical trials by proactively monitoring study progress, milestones, risks, project timelines, work plans, trackers, and turnaround times.
- Support and oversee study start up, conduct, and close out activities by ensuring readiness, completeness, and quality of required documentation.
- Lead the preparation, review, and finalization of internal and external Kick Off meeting materials, site start-up communications, Study Start Up, Vendor, and Close out checklists.
- Assist the PM with hosting the external sponsor meetings. Independently draft, coordinate, and distribute internal and external meeting agendas and minutes; actively drive action item completion, follow ups, and accountability across stakeholders.
- Prepare, analyze, and deliver high quality project status updates, metrics, dashboards, and reports to internal teams and external sponsors, highlighting trends, risks, and operational insights.
- Serve as a primary operational point of contact for Clinical Project Coordinators (CPC), providing guidance and oversight on imaging site activities including site communications, evaluations, training coordination, and query resolution.
- Provide oversight and subject matter expertise to CPCs in maintaining the electronic Trial Master File (eTMF), ensuring ongoing accuracy, completeness, and inspection readiness. Lead and/or oversee eTMF QC and reconciliation activities, including ongoing QC and study close out tasks.
- Support audits and inspections by coordinating the collection and review of objective evidence as well as supporting deviation management and CAPA documentation.
- Maintain and oversee study data and systems, including study reporting, metrics tracking and reader dossier preparation, ensuring data quality and consistency across systems.
- Review and support billing activities, including monthly billing and forecasting,



routine overbilling reconciliation, and study close out reconciliation, identifying discrepancies and ensuring timely resolution.
- Support PMs with ongoing deliverables and real-time reporting. Independently manage assigned project activities, exercising sound judgment and decision making.
- Serve as a reliable back up for the PM and/or CPCs during their absence, assuming operational ownership to ensure continuity of project execution and effective communication with internal and external stakeholders.
- Ensure consistent compliance with protocols, SOPs, regulatory requirements, HIPAA, and data protection standards; proactively identify compliance risks and support corrective actions.
- Perform other duties as assigned by supervisor.

EDUCATION AND EXPERIENCE

- Bachelor s degree in a science or health-related field is required.
- Minimum of 2 years of relevant experience in a project support role is required.
- Minimum of 2 years industry experience is required (clinical CRO or pharmaceutical industry).
- 2+ years experience in medical imaging within clinical trial environment preferred.
- Knowledge of Valuable Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trial setting is required.
- Knowledge of key project management terminology and tools is preferred.

GLOBAL PROJECT SPECIALIST II

RESPONSIBILITIES

- All responsibilities of GPS plus:
- Provide onboarding, training, and ongoing mentoring to new GPS personnel; serve as a resource for processes, systems, and best practices, and contribute to training materials and knowledge sharing initiatives.

EDUCATION AND EXPERIENCE





- Bachelor s degree in a science or health-related field is required
- Minimum of 3 years of relevant experience in a project support role is required.
- Minimum of 3 years industry experience is required (clinical CRO or pharmaceutical industry).
- 3+ years experience in medical imaging within clinical trial environment preferred.
- Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trial setting is required
- Knowledge of key project management terminology and tools is preferred.
- Experience with global Phase III clinical trials with imaging components required.

SKILLS

- Proficiency in MS Office and internet applications is required.
- Service-oriented approach, flexible, and proactive toward adapting to client needs.
- Ability to independently manage multiple projects, collaborate effectively, and meet tight deadlines.
- Must have superior attention to detail including excellent oral and written communication skills.
- Must have strong time management and organization skills.
- Ability to excel in a team environment.
- Ability to strictly adhere to all procedures, rules, and regulations while maintaining the confidentiality of sensitive data, records, files, and communications.
- Ability to prioritize workload to meet changing day to day business needs while effectively understanding and leading technical research activities within a research environment.

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Global Project Specialist (Uttar Pradesh)
🏢 Imaging Endpoints
📍 Uttar Pradesh