Sr. Principal Clinical Study Manager- REMOTE
Boston, Massachusetts | , Remote
ResponsibilitiesLocation Boston, MassachusettsUS Job ID JR-023140
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
If you are seeking a meaningful, impactful, and stimulating career, look no further.
PerkinElmer is seeking a Clinical Study Manager to join their Quality Regulatory and Medical team. The Clinical Study Manager will be experienced in the execution and monitoring of in vitro diagnostics studies. The clinical responsibilities include the oversight and execution of product registration studies, feasibility studies, post-launch studies and collaboration with medical facilities and clinical research organizations to support sample acquisition in support of R&D and service laboratory activities
•Planning, executing, and managing clinical projects and service laboratories
.•Primary interface in North America for clinical sites and cross-functional project teams ensuring study execution is on-time and within budget.
•Protocol development and/or review to assure compliance with regulatory requirements and alignment with study objectives.
•Responsible for clinical trial conduct at multiple external sites including monitoring clinical trial conduct at external site(s).
•Coordinating with medical facilities and clinical research organizations to support sample acquisition activities for R&D and service laboratory projects.
•Initiate, coordinate, and take responsibility for developing supporting documents (such as informed consent, case report
forms, etc.) related to study conduct, including source documentation, monitoring and study guidelines, and training materials to assure compliance with regulatory requirements and alignment with study objectives. •Conduct remote data monitoring and on-site monitoring visits (training, monitoring, close-out) in accordance with Federal regulations (FDA & Health Canada), Good Clinical Practices, ICH guidelines and standard operating procedures. •Establish professional rapport and frequent communication with clinical study site personnel.
•Generation of study reports.
•Monitor changes in governing authorities
•Other responsibilities as assigned
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
- Bachelor’s degree in Life Sciences
- 12+ years of experience in quality systems, regulatory or clinical studies within the medical device or pharmaceutical industry.
- 5-8 years of management experience.
- Master’s degree preferred or equivalent work experience
- Successful experience working with global cross-functional teams across multiple work locations
- Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners.
- Exceptional attention to detail.
- Ability to take direction and multi-task in a fast-paced environment.
- Ability to work independently with minimal supervision
- Superior interpersonal, verbal, and written communication skills.
- Up to 25% travel
- Exceptional organizational, negotiation, and problem-solving skills.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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