Clinical Quality Operations Manager Jobs

Bachelor's degree in Nursing, Business Management, Human Resources or a related field

Manage customer complaints and make appropriate improvements. Investigate alleged incidents reported by clients and when appropriate advocate for Nursa clinicians

Healthcare and technology industry experience a plus

Experience working with CRM software like Salesforce

Experience building and managing off-shore teams a plus

Strong analytical skills leveraging data

Project Management experience is a must

Quality event management experience is a must

Ensures final endorsement of document(s) prior to coordinating approval workflows in the Document Management System (DMS).

Typically requires 8-10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry

Sponsor/CRO GCP experience required (experience in a Clinical Project Manager role is ideal)

Strong interest and understanding of Process/Controlled Document Management – this can be trained for the right person

Solid project and vendor management, analytical and problem solving skills.

Bachelor's Degree & 5+ years of experience in the pharmaceutical industry performing in a clinical operations function.

This is a 12+ month contract with benefits!

Managing all aspects of study progress from start-up to close-out activities and end of study reporting

Coordinating interdisciplinary activities throughout the study

Strong 2 years' direct Line Management experience managing and recruiting CRA/SCRAs.

Effective organizational and time management skills.

Act as back-up for colleagues in SM management team

Performance management: objectives, mid-year and end-year evaluation, management of underperformance

Bachelor's degree or combination of education and experience.

Ability to establish and maintain effective working relationships senior management, peers, direct reports, and clients.

Excellent organizational and time management skills, with the ability to prioritize and manage competing priorities effectively.

Strong leadership and team management skills, with the ability to motivate and inspire teams to achieve project objectives.

Proficiency in utilizing trial management systems and electronic data capture systems.

Manage trial budgets and resources, ensuring efficient allocation and utilization to meet project timelines and deliverables.

Ensure compliance with regulatory requirements and ethical standards, maintaining a high level of quality and integrity in all clinical operations activities.

Minimum of 6 years of experience in clinical operations within the scientific industry.

Minimum four (4) years of relevant experience directly managing staff in a health care setting, including management of CRAs.

Perform resource management activities to ensure CRAs are assigned to clinical trials in time to meet trial needs.

Immediately report any clinical trial fraud, misconduct, or serious breaches to the TD2 PM and TD2 senior management.

Overall knowledge of GCP, ICH, and FDA regulatory requirements governing human clinical trials, with detailed knowledge related to clinical monitoring.

Create and manage department timelines with proactive timeline communication.

Minimum eight (8) years of experience in a pharmaceutical/biotech/CRO industry with progressive experience working on clinical trials.

Strong analytical, problem-solving, and project management skills.

Strong knowledge of FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations

Develop training materials to ensure that Quality Operations employees meet the requirements of the company and clients.

7+ years of Quality Assurance experience in a GXP related field within the biotechnology, biologics, or pharmaceutical industry

Excellent interpersonal, verbal, and written communication skills are meaningful in this collaborative work environment

Experience reviewing and releasing Final Product preferred

Quality Improvement and project management training/experience

Management and oversight of automated population health solutions and electronic systems reporting.

Manage internal and external partner relationships across multiple departments and external organizations.

Partner closely with health centers as well as performance managers to drive positive outcomes

Experience working in or with primary care organization and conducting outreach to improve engagement in care

Experience facilitating teams in improvement initiatives

Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.

Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.

Experience with delivering effective CAPA management solutions.

Experience with risk management tools and processes within the clinical quality framework.

Excellent project management and organizational skills.

Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.