Clinical Program Manager

Job Description

Job Description Job ID: CEP004799
About Us
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at [ Link Removed ] or follow us on Twitter (@CepheidNews).
Description
The Clinical Program Manager, reporting to the Sr. Director of Clinical Affairs, is responsible for managing global clinical trials and programs associated with Cepheid’s infectious disease programs to support US and ex-US registrations. A primary function of this role is to represent Clinical Affairs on cross-functional teams and ensure direct report(s) have the appropriate skills, training and professionalism to conduct multi-center global clinical trials on behalf of Cepheid and work with them to achieve company and professional goals.Responsibilities include following:• Management of Associates• Leads and inspires Clinical Research Associate(s) through clear communication and setting examples• Sets clear objectives and works with Associates to develop solid development goals and meaningful plans for achievement in alignment with company goals; conducts performance appraisals• Develops and implements training plans to ensure compliance with Cepheid Quality Systems, regulatory requirements, study protocols, department SOPs and other as required• Assesses clinical study team resource needs in conjunction with other managers within Clinical Operations to ensure projects are resourced appropriately• Represents the Clinical Affairs function on core teams and acts as a cross functional liaison to ensure study plan aligns with business development strategies• Manages the execution and operational plan of global clinical trials projects and programs including timeline and deliverables as well as developing and managing the approved budget throughout the lifetime of the trials• Responsible for ensuring that clinical protocols are developed, reviewed and approved in accordance with the master schedule• Ensures investigational site qualification and monitoring (initiation, interim and closeout) are conducted according to predeveloped plans and Cepheid SOPs• Responsible for the development of study-specific documents (e.g. clinical monitoring plans, case report form content, informed consents, etc.)• Reviews and contributes to the development of data management plans, statistical analysis plans, and EDC • Manages the clinical budget and develops contingency plans for clinical trials• Monitors adherence to clinical protocols• Plans, oversees and conducts initial and ongoing training for relevant study staff on clinical projects• Assists regulatory team with reviewing documents for product submissions Job Requirements
Qualifications
• Bachelor’s degree in a scientific discipline or equivalent experience• 9+ years of clinical research experience within medical device (IVD preferred), biotech, or pharmaceutical• Excellent organizational and project management skills• Previous project lead or project management experience is required• Strong oral and written communication skills; strong technical writing skills• Strong knowledge and understanding of FDA and IVDR requirements, ICH Guidelines, and GCPs governing the conduct of routine clinical trials• Ability to travel up to 30%PREFERRED QUALIFICATIONS:• A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology Biochemistry and/or Human Physiology is preferred• IVD experience is highly desired• Experience working with infectious diseases is strongly preferred
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.