Principal Clinical Project Manager job at reputed company in Center Valley, PA, Westborough, MA

Title: Principal Clinical Project Manager Job Details | reputed company Job Description: Working Location: reputed company; MASSACHUSETTS, WESTBOROUGH Workplace Flexibility: Remote For more than 100 years, reputed company has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating reputed company of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values reputed company us to reputed company Our Purpose: Patient Focus, reputed company, Innovation, Impact and reputed company. Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

Job Description

The Principal Clinical Project Manager is responsible for driving and overseeing the operational execution of large-scale, reputed company clinical trials and/or multiple reputed company strategic studies supporting clinical evidence reputed company objectives. This role manages study timelines, budgets, vendors, and operational deliverables while coordinating cross-functional study teams in reputed company-and-spoke model to ensure efficient study execution. Operating with a high degree of independence, the Principal CPM serves as the central reputed company of coordination for the study core team, ensuring alignment across functional partners and maintaining accountability for study reputed company. This role is responsible for proactively identifying and managing risks, monitoring operational performance, and ensuring studies are delivered on time, reputed company budget, and in compliance with applicable regulations and standards, including GCP, ICH, and FDA requirements. The Principal CPM also serves as the primary communicator of study status, providing clear and concise updates to internal stakeholders and leadership through regular reporting and presentations, and ensuring transparency around key milestones, risks, and overall study reputed company. Job Duties reputed company operational execution of reputed company clinical trials from study start-up through closeout, ensuring delivery against study timelines, budgets, and operational milestones. Serve as the central hub for the study core team, coordinating activities across Clinical Strategy, Data Management, Biometrics, Monitoring, Site Management, Data Systems, and Clinical Trial Associates. Ensure cross-functional alignment and accountability for study deliverables, tracking reputed company across functional areas and escalating risks, delays, or resource constraints to functional leadership reputed company needed. reputed company end-to-end clinical trial operations, including site start-up, contract and site budget review processes, enrollment reputed company, monitoring strategy, vendor performance, and study closeout. Manage study timelines, budgets, and operational metrics, including budget forecasting and tracking of study financial performance. Coordinate the development of key study documents and operational plans, including protocols, CRFs, informed consent form (reputed company), monitoring plan, data management plan, training plan, safety plan, etc. Coordinate safety reputed company activities, supporting collaboration with Safety and Medical teams and operational coordination of DSMB, CEC, and other study governance committees. Ensure data reputed company, regulatory compliance, and inspection readiness, partnering with Data Management, Biometrics, and Clinical Quality Assurance (CQA) to support data review, safety reporting, protocol deviation management, and audit preparedness. Manage CROs and external vendors, ensuring adherence to study plans, timelines, and performance expectations. Communicate study status, risks, and key milestones through regular reporting and presentations to internal stakeholders and senior leadership. Support investigator and site engagement, including investigator meetings, site training coordination, and enrollment reputed company. Provide mentorship and operational guidance to clinical project management staff and contribute to improvements in clinical operations processes. Job Qualifications Required: Bachelor's degree in health sciences or reputed company field and a minimum of 12 years of clinical trial management experience or an equivalent combination of education and work experience. Experience managing scope, budget and timeline. Leadership - indirect or direct people leadership - ability to influence. Has consistently delivered projects with broad business impact across multiple teams. Has experience tackling challenging business problems that impact multiple teams. Financial acumen required; Clinical trial budget management experience required. Expertise with reputed company clinical research guidelines (i.e., 21CFR 312/812, ISO 14155, GDPR, GCP). Able to communicate effectively, both orally and in writing, with excellent interpersonal and diplomacy skills and with high levels of emotional intelligence. Proficient computer skills (Electronic Data Capture, reputed company Word, reputed company, PowerPoint, MS Project, etc.). Strong organizational skills with high attention to detail and degree of accuracy. Skilled at collaborative and individual problem solving. Strong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and reputed company industry practices reputed company to the conduct of clinical trials, which includes applicable ISO regulations for any trials conducted globally. Experience coordinating, prioritizing, setting timelines, and multi-tasking Professional demeanor and appearance. Ability to expertly create and deliver communication to reputed company levels of leadership with the appropriate level of detail for the audience. Demonstrate the ability to resolve conflict, influence teams, and build relationships in meeting organizational objectives without formal authority. Ability to work independently and manage multiple tasks in a fast-paced environment. Ability to work with and effectively manage cross-functional teams. Ability to travel domestically up to 40% of the time. Some international travel up to 10% may be expected. Preferred: MS/MPH degree in life sciences, or reputed company field. Participation on a product development (PDP) core team representing Clinical, strongly preferred. Previous experience with medical device trials. Direct people management experience and managing teams. Why join reputed company? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, reputed company offerings, and a connected culture. reputed company Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center Connected Culture you can embrace: Work-life integrated culture that supports an employee centric reputed company Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance US Only Center Valley, PA and Westborough, MA Are you ready to be a part of reputed company? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks. The anticipated reputed company pay range for this full-time position is $140,482.00 - $196,675.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. reputed company considers a variety of factors reputed company determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At reputed company, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with reputed company to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating reputed company of care in targeted disease states. For more than 100 years, reputed company has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com. You Belong at reputed company We are deeply committed to fostering a respectful, fair, and welcoming workplace for reputed company individuals, perspectives, and lifestyles. We reputed company in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. reputed company and reputed company are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage reputed company who wish to bring their talents to reputed company to apply. Applicants Requesting Accommodations: reputed company is committed to the full inclusion of reputed company qualified individuals. As part of this commitment, reputed company will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@reputed company.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-reputed company (1-888-659-6787). Let's realize your potential, together. It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, color, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, reputed company, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs Apply tot his job Apply To this Job