Project Manager Clinical Affairs

Job Title: Project Manager Clinical Affairs (Clinical Quality)
Location: Remote
Duration: 12 months

Company Description
At Client, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Client has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position

The Project Manager, Clinical Affairs Clinical Quality is responsible for providing oversight for clinical quality and compliance activities across U.S. and global clinical studies, including first-in-human, pivotal trials intended for regulatory submission, and post-market studies.

This individual will support the development, maintenance, and continuous improvement of clinical quality processes, operating procedures, best practice guidelines, and oversight frameworks to ensure alignment with internal requirements and applicable external regulations, including 21 CFR, ISO 14155, and other regional or local requirements.

As a key cross-functional partner, this role will collaborate closely with Regulatory Affairs, Quality Compliance, Program Management, Clinical Affairs, Post-Market Surveillance, Regulatory Compliance, Training, Legal, and other stakeholders to strengthen inspection readiness, support compliance execution, and enable achievement of business and clinical quality objectives.

Roles and Responsibilities

Accountable for supporting assigned clinical quality compliance activities including:
Audit & Monitoring: Conduct routine internal/external audits and ongoing clinical file or documentation reviews to identify compliance discrepancies to ensure sponsor audit/inspection readiness
Regulatory Compliance: provide internal oversight of clinical studies to ensure compliance to Good Clinical Practice (GCP) guidelines, FDA regulations, ISO14155 standards, and other applicable global requirements.
CAPA Management: Assist project teams with develop, implement, and track Corrective and Preventive Action (CAPA) plans to resolve audit findings and prevent future non-compliance.
Risk Management: Identify potential clinical quality risks, escalate compliance issues to leadership, and facilitate root cause analyses (RCAs).
Policy & Training: Support the development of Standard Operating Procedures (SOPs), best practice guidelines, clinical quality processes and tools and deliver training to ensure clinical staff are educated on quality frameworks.
Partner with internal stakeholders to develop internal processes, KPIs and drive identified initiatives,
Support the development and execution of a proactive, risk-based clinical quality and compliance program that safeguards participant safety, supports data integrity, and promotes continuous improvement across all clinical studies.
Qualifications

Skill/Job Requirements

Competency Requirements: (Competency is based on education, training, skills and experience.) In order to adequately perform the responsibilities of this position the individual must have:

Minimum Education:
Bachelor's degree in a scientific/bioengineering field (B.S.) with a minimum of 5 years of experience in clinical research.
Strong organizational and project management skills, with strong experience of collaborating with cross-functional teams
Prior experience working in Clinical Quality Compliance
Strong knowledge of 21 CFR part 812, Good Clinical Practice ICH/GCP, ISO14155 and other regulations/guidelines.
Fundamental knowledge of clinical research and monitoring requirements
Previous experience supporting internal and external audit on clinical studies is preferred
Strong communication, presentation and interpersonal skills with high attention to detail and organization
Ability to learn quickly, tailor to shifting requirements,
Results-driven attitude and strong problem-solving skills, consistently show dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
Must be able to travel 25-40% or based on business requirements