Senior Clinical Trial Manager — Medical Device (Hybrid — Arbor Lakes, MN) Possib
Pharmavise Corporation, Osseo, MN, United States
Overview
The Senior Manager, Clinical Trials provides strategic and operational leadership to Clinical Trial Managers and associated study staff in support of global clinical programs. This role is accountable for the planning, execution, and oversight of RDN clinical trials, ensuring alignment with program strategy, timelines, budgets, quality standards, and regulatory requirements. The Senior Manager drives clinical excellence across studies, oversees vendor performance, and ensures audit readiness throughout the lifecycle of each trial.
Responsibilities
Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high-performance, collaborative team environment.
Oversee end to end operational execution of global clinical trials, ensuring adherence to protocol, GCP, SOPs, and applicable regulatory requirements.
Translate program strategy into operational plans, timelines, and resource needs; ensure cross-functional alignment and timely delivery of study milestones.
Oversee development and maintenance of study documentation, including operational plans, study materials, systems, and regulatory submissions.
Manage CROs and external vendors, including selection, contracting, performance oversight, issue escalation, and budget tracking.
Lead proactive risk identification, mitigation planning, and contingency management across assigned studies.
Provide clear, data-driven study updates, risk assessments, and recommendations to clinical leadership and governance bodies.
Manage clinical trial budgets, including forecasting, accruals, variance analysis, and financial oversight of vendor contracts.
Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment, engagement, and study success.
Ensure inspection readiness and compliance with internal quality standards, audit findings, and regulatory expectations.
Champion continuous improvement in clinical operations processes, tools, and best practices.
Required Qualifications
Bachelor’s degree in a scientific or healthcare discipline; advanced degree preferred.
10 years of experience in clinical research, including global clinical trials and vendor management.
5 years of demonstrated leadership experience managing and developing clinical trial staff, preferred.
Strong understanding of GCP, ICH guidelines, and global regulatory requirements.
Proven ability to manage complex timelines, budgets, and cross-functional deliverables.
Excellent communication, negotiation, and stakeholder-management skills.
Ability to navigate ambiguity, drive decision-making, and influence across levels of the organization.
Proven exposure and experience to internal audits and regulatory body audits.
Ability to work in a fast-paced environment requiring support of multiple studies and direct reports simultaneously.
Other Details
Schedule: 08:00 AM – 04:30 PM (PST)
Work Setup: Hybrid — Arbor Lakes, MN
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The Senior Manager, Clinical Trials provides strategic and operational leadership to Clinical Trial Managers and associated study staff in support of global clinical programs. This role is accountable for the planning, execution, and oversight of RDN clinical trials, ensuring alignment with program strategy, timelines, budgets, quality standards, and regulatory requirements. The Senior Manager drives clinical excellence across studies, oversees vendor performance, and ensures audit readiness throughout the lifecycle of each trial.
Responsibilities
Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high-performance, collaborative team environment.
Oversee end to end operational execution of global clinical trials, ensuring adherence to protocol, GCP, SOPs, and applicable regulatory requirements.
Translate program strategy into operational plans, timelines, and resource needs; ensure cross-functional alignment and timely delivery of study milestones.
Oversee development and maintenance of study documentation, including operational plans, study materials, systems, and regulatory submissions.
Manage CROs and external vendors, including selection, contracting, performance oversight, issue escalation, and budget tracking.
Lead proactive risk identification, mitigation planning, and contingency management across assigned studies.
Provide clear, data-driven study updates, risk assessments, and recommendations to clinical leadership and governance bodies.
Manage clinical trial budgets, including forecasting, accruals, variance analysis, and financial oversight of vendor contracts.
Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment, engagement, and study success.
Ensure inspection readiness and compliance with internal quality standards, audit findings, and regulatory expectations.
Champion continuous improvement in clinical operations processes, tools, and best practices.
Required Qualifications
Bachelor’s degree in a scientific or healthcare discipline; advanced degree preferred.
10 years of experience in clinical research, including global clinical trials and vendor management.
5 years of demonstrated leadership experience managing and developing clinical trial staff, preferred.
Strong understanding of GCP, ICH guidelines, and global regulatory requirements.
Proven ability to manage complex timelines, budgets, and cross-functional deliverables.
Excellent communication, negotiation, and stakeholder-management skills.
Ability to navigate ambiguity, drive decision-making, and influence across levels of the organization.
Proven exposure and experience to internal audits and regulatory body audits.
Ability to work in a fast-paced environment requiring support of multiple studies and direct reports simultaneously.
Other Details
Schedule: 08:00 AM – 04:30 PM (PST)
Work Setup: Hybrid — Arbor Lakes, MN
#J-18808-Ljbffr