Principal Clinical Quality Specialist

ORCHESTRA BIOMED, INC.; New Hope (Bucks County); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking biomedical innovation company as a Principal Clinical Quality Specialist, where you will play a pivotal role in ensuring the quality and compliance of clinical studies. In this dynamic position, you will collaborate with cross-functional teams, conduct audits, and monitor clinical data integrity. Your expertise in Good Clinical Practices and regulatory compliance will drive continuous improvement in clinical systems. Enjoy a comprehensive compensation package, including health insurance, 401(k), and more, while contributing to groundbreaking medical innovations that enhance patient care.

Benefits

Health Insurance

401(k)

Paid Holidays

PTO & Sick Time

Life & AD&D Insurance

Disability Insurance

Dental Insurance

Vision Insurance

Pet Insurance

Qualifications

• Minimum 7 years’ experience in clinical quality or related role.
• Knowledge of clinical/GCP requirements and regulatory compliance.

Responsibilities

• Conducting GCP audits and leading clinical quality activities.
• Monitoring integrity of clinical data and documentation.

Skills

Clinical Quality Management

Good Clinical Practices (GCP)

Regulatory Compliance

Analytical Skills

Problem-Solving Skills

Communication Skills

Education

Bachelor’s degree in Life Sciences

Healthcare Administration

Tools

Clinical Trial Management Systems

Electronic Data Capture Platforms

Microsoft Suite

Job description

About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Job Summary

A Principal Clinical Quality Specialist plays a crucial role in ensuring the quality and compliance of clinical studies for drugs and medical devices. This position supports all aspects of clinical quality management, with a focus on maintaining adherence to Good Clinical Practices (GCPs) and applicable regulatory requirements. The specialist works closely with cross-functional teams to develop, implement, and oversee quality assurance processes throughout the clinical trial lifecycle.

Role and Responsibilities – Including but not limited to:

• Conducting GCP, investigator site, vendor, Trial Master File (TMF), and/or system audits
• Leading clinical quality activities per respective clinical protocol and plans
• Collaborating with clinical team members to support changes to clinical documents or plans
• Monitoring and review of integrity of clinical data and clinical investigation documentation
• Ensuring that all processes contributing to the performance of a clinical trial are conducted properly including but not limited to supplier management/qualification, inventory control, risk management activities and training
• Spearheading continuous improvement of clinical systems and procedures, change management activities and change impact assessments
• Collaborating with Clinical team on Clinical Risk Management activities and identifying, assessing and proposing mitigations to risks that could affect patient safety or study conduct
• Identifying compliance issues and leading issue investigations, root cause analyses, and implementation of corrective and preventive action plans
• Collaborating with internal and external stakeholders to align quality strategies with organizational goals
• Generating reports on quality performance for any clinical or management reviews
• Identifying and communicating any critical compliance risks to management
• Leading or assisting in the preparation and coordination of regulatory agency inspections and/or audits and inspections on GCP-related matters
• Other tasks may be assigned based on business needs

In order to be employed by Orchestra Biomed, a current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. The level of this position will be based on the final candidate’s qualifications.

Qualifications – Knowledge & Skills:

• Bachelor’s degree in Life Sciences, Nursing, Healthcare Administration or related field
• Minimum 7 years’ experience in clinical quality or related role in the pharmaceutical or medical device industry
• Knowledge of clinical/GCP requirements (ISO 14155, 21 CFR Part 812, ICH E6, etc.)
• Experience in GCP auditing and risk-based quality management approaches
• Experience with clinical trial management systems and electronic data capture platforms preferred
• Good Clinical Practice certification or training preferred
• Knowledge of regulatory requirements (FDA, GxP, ISO) for drug products, combination device and/or medical devices and experience with clinical quality/compliance systems a plus
• Proficient understanding of clinical research processes and terminology
• Excellent analytical and problem-solving skills
• Superior attention to detail and ability to manage multiple projects simultaneously
• Strong communication (verbal and written) and interpersonal skills
• Proficient in Microsoft Suite (Word, Outlook, Excel, PowerPoint)

Why Join Orchestra BioMed

In addition to an interesting, inclusive, and collaborative work environment, Orchestra BioMed is proud to offer a comprehensive compensation package. Along with a competitive salary, including annual bonus and equity eligibility, health insurance (for employee and family), prescription drug coverage, 401(k), paid holidays, PTO & sick time, Life & AD&D insurance, disability insurance, dental, vision, pet insurance and more.

Our Vision

To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.

Our Mission

We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners and stakeholders.

Our Values

• We care about patients, physicians, partners, and each other
• We are creative , open-minded, adaptable and think “outside the box”
• We are driven to always do our best and we do not give up
• We deliver and are accountable to promised results

EQUAL OPPORTUNITY EMPLOYER Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Important notice to employment businesses/agencies

Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.