Sr. Manager, Process Excellence & Delivery (Clinical Trial Data Services)

Randstad Life Sciences US; Cambridge (MA); Remote; USD 100,000 - 125,000; Full time

Job summary

A leading company in clinical trial data services is seeking a Senior Manager to oversee process excellence and delivery. The role involves defining processes for quality data delivery, ensuring compliance, and leading cross-functional initiatives. Ideal candidates will have a background in life sciences and extensive experience in clinical data management and delivery. This position offers a remote contract for 12 months with competitive hourly pay.

Qualifications

• 6+ years in pharmaceutical or clinical research organization.
• Experience with clinical trial technologies.

Responsibilities

• Support and lead process design and governance for GICTDS functions.
• Collaborate with stakeholders to support process implementation.
• Identify opportunities for process improvement in clinical trial data.

Skills

SOP

CRF

Clinical Data Management

GCP

CTMS

EDC

ICH Regulations

Education

Bachelor's Degree

Tools

EDC

IRT

eCOA

CTMS

TMF

Job description

Sr. Manager, Process Excellence & Delivery (Clinical Trial Data Services)

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Job Summary

The Senior Manager, Process Excellence and Delivery supports the strategy to develop and maintain quality Global Integrated Clinical Trial Data Services (GICTDS) processes for clinical trial data delivery, study reporting, and inspection readiness. They define processes to ensure complete, accurate, high-quality, regulatory-compliant data in support of publications and regulatory submissions.

In partnership with functional stakeholders and with Global Development Compliance, they contribute to and may lead within-function and cross-function process definition, training, and change management activities to successfully deliver the operational strategy.

Contract Details

• Remote | 12 Months
• Salary: $70.00 - 83.50 per hour
• Work hours: 9 to 5

Responsibilities

• Support and may lead process design and governance for GICTDS functions such as Clinical Data Management, Clinical Data Engineering, Clinical Data Standards, and others.
• Partner with Global Development Compliance GDC GCP Process Excellence to develop and implement these processes.
• Serve as functional process lead or business process owner delegate for specific processes, liaising with GDC on improvements and serving as process expert.
• Collaborate with stakeholders to support process implementation and maintenance across the network.
• Contribute to the development of new processes and technologies in compliance with quality standards.
• Monitor metrics and feedback to ensure process health and performance.
• Identify opportunities for process improvement in clinical trial data delivery and reporting.
• Support the strategy to achieve GICTDS goals through innovative solutions.

Qualifications

• Bachelor's Degree or international equivalent; Life Sciences preferred.
• 6+ years in pharmaceutical or clinical research organization, including clinical data management and delivery.
• Experience with clinical trial technologies like EDC, IRT, eCOA, CTMS, TMF, and related systems.
• Strong teamwork, organizational, and communication skills.
• Knowledge of FDA and ICH-GCP guidelines.

Preferred

• Global/international experience and collaboration skills.

Skills: SOP, CRF, Clinical Data Management, GCP, CTMS, EDC, ICH Regulations.

We are an Equal Opportunity Employer and support applicants with accommodations during the hiring process.