Massachusetts Staffing
Clinical Project Manager
Join the Breast and Skeletal Health Clinical Affairs team as a Clinical Project Manager, leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, and with the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs, Program Management, Legal, Marketing, and Operations to deliver world-class evidence supporting breast and skeletal health technologies. We would prefer to have someone in Newark, DE or Marlborough, MA but open to Remote. Key Responsibilities: Lead planning and execution of complex clinical studies from protocol design to study closure, ensuring adherence to budget, scope, and schedule. Coordinate cross-functional clinical teams (monitoring, data management, statistics, medical writing, medical monitoring, safety) for timely and proper project completion. Develop and manage advanced clinical programs supporting product development and evidence generation. Ensure all studies comply with domestic and international regulations and standards (GCP, ICH). Build and manage high-performing clinical operations frameworks and teams. Partner with Clinical Development on study design and reporting. Create, review, and maintain study documents (protocols, informed consent, manuals, eCRFs, IRB submissions, IDE applications). Select and oversee CROs and vendors, including contract negotiations and activity management from award to close-out. Manage clinical budgets and pricing strategies using cost models. Contribute expertise to strategic study design discussions and cross-functional planning. Support regulatory filings and interactions; prepare documentation for product files (e.g., MDR Clinical Evaluation Reports). Maintain division research records on domestic and international databases (e.g., ClinicalTrials.gov). Lead annual Sunshine Act reporting and ensure documentation is catalogued in quality management systems. Physical Demands: Ability to sit and use hands for computer and office equipment. Ability to travel up to 25%. Qualifications: Bachelor's or Master's Degree required; advanced degree (Master's, PhD) preferred. 8+ years clinical research/operations experience (6+ years with Master's, 3+ years with PhD). Experience in academic-industrial partnerships and with sponsors or CROs in the medical device industry. Proven track record managing complex clinical studies and trials. Experience in breast cancer screening, diagnostics, and treatment preferred. Deep understanding of medical device regulations, GCP, clinical terminology, workflows, and trial design. Excellent oral, written, and presentation skills; able to communicate across diverse stakeholder groups. Strong interpersonal skills, attention to detail, and deadline-driven. Strategic thinker with outstanding organizational and project management abilities. Collaborative, adaptable, and able to manage multiple priorities in a matrixed environment. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme. The annualized base salary range for this role is $116,500 - $182,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Join the Breast and Skeletal Health Clinical Affairs team as a Clinical Project Manager, leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, and with the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs, Program Management, Legal, Marketing, and Operations to deliver world-class evidence supporting breast and skeletal health technologies. We would prefer to have someone in Newark, DE or Marlborough, MA but open to Remote. Key Responsibilities: Lead planning and execution of complex clinical studies from protocol design to study closure, ensuring adherence to budget, scope, and schedule. Coordinate cross-functional clinical teams (monitoring, data management, statistics, medical writing, medical monitoring, safety) for timely and proper project completion. Develop and manage advanced clinical programs supporting product development and evidence generation. Ensure all studies comply with domestic and international regulations and standards (GCP, ICH). Build and manage high-performing clinical operations frameworks and teams. Partner with Clinical Development on study design and reporting. Create, review, and maintain study documents (protocols, informed consent, manuals, eCRFs, IRB submissions, IDE applications). Select and oversee CROs and vendors, including contract negotiations and activity management from award to close-out. Manage clinical budgets and pricing strategies using cost models. Contribute expertise to strategic study design discussions and cross-functional planning. Support regulatory filings and interactions; prepare documentation for product files (e.g., MDR Clinical Evaluation Reports). Maintain division research records on domestic and international databases (e.g., ClinicalTrials.gov). Lead annual Sunshine Act reporting and ensure documentation is catalogued in quality management systems. Physical Demands: Ability to sit and use hands for computer and office equipment. Ability to travel up to 25%. Qualifications: Bachelor's or Master's Degree required; advanced degree (Master's, PhD) preferred. 8+ years clinical research/operations experience (6+ years with Master's, 3+ years with PhD). Experience in academic-industrial partnerships and with sponsors or CROs in the medical device industry. Proven track record managing complex clinical studies and trials. Experience in breast cancer screening, diagnostics, and treatment preferred. Deep understanding of medical device regulations, GCP, clinical terminology, workflows, and trial design. Excellent oral, written, and presentation skills; able to communicate across diverse stakeholder groups. Strong interpersonal skills, attention to detail, and deadline-driven. Strategic thinker with outstanding organizational and project management abilities. Collaborative, adaptable, and able to manage multiple priorities in a matrixed environment. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme. The annualized base salary range for this role is $116,500 - $182,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.