Senior Clinical Project Manager

Job description

Working Location: Massachusetts, Westborough; Pennsylvania, Center Valley Workplace Flexibility: Hybrid For more than 100 years, Olympus 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 the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: . Job Description The Senior Clinical Project Manager (CPM) is responsible for assisting with the execution of high-quality clinical studies and will focus on the oversight and monitoring of investigational data to ensure compliance. Job Duties Leads and drives the project team in the planning, execution and management of all operational aspects of large-scale, complex, and/or business critical clinical trials. Leads, directs and executes clinical studies worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures. Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions. Owns and manages the clinical trial budget including developing the budget, forecasting, and accruals. Participates in the site qualification, activation and initiation process, including budget and contract management and review of site activation documentation Ensures the project team maintains a continuous state of audit readiness. Prepares study related documents including clinical protocols, informed consent forms, case reports forms, monitoring plans, study manuals, and other study related tools. Assists in data management with query generation and resolution, and reporting of adverse events and protocol deviations. Assists with the development and implementation of site corrective actions as needed to address any compliance issues. Assists with study training for investigators and coordinators, contract research organization (CRO), Data and Safety Monitoring Board (DSMB) and/or Clinical Events Committee (CEC), or core labs Manages partnership with CRO and other external vendors. In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks. Informs and presents study progress and known risks to Senior Leadership. Assists in the planning of, and preparing materials for, investigator and coordinator meetings Ensures that appropriate resources (personnel, tools, etc.) are maintained for Quality System compliance and audit readiness May coordinate, schedule, and conduct monitoring visits at investigational sites to ensure compliance to the clinical protocol, regulations, and timely receipt of data including source document verification, writing or reviewing monitoring reports and follow up letters, and device accountability Mentors and coaches all levels of the Clinical team. Job Qualifications Required: Bachelor’s degree in health sciences or related field and Minimum of 5-7 years of clinical trial management experience or an equivalent combination of education and work experience. 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. Microsoft Word. Excel. PowerPoint. MS Project. 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 current industry practices related 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 all 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. Experience managing scope, budget and timeline. 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 complex clinical research guidelines: 21CFR 312/812. ISO 14155. GDPR. GCP. Preferred: Previous experience with medical device trials, preferably as a sponsor. MS/MPH degree in life sciences, or related field. Participation on a product development (PDP) core team representing Clinical. Strongly preferred. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable 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 mindset 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 our team? Learn more about our benefits and incentives: . At Olympus, 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 healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus 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, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, 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 . You Belong at Olympus We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact . If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related 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, ancestry, 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) || Massachusetts (US-MA) || Westborough || Medical Affairs