Merck Clinical Operations Manager Jobs in Detroit, MI

As a Clinical Imaging Operations Lead, you will have a leading role in the design and execution of key strategic and operational aspects of complex early and late phase clinical trials across multiple therapeutic areas, where imaging is a primary or key endpoint. You will collaborate with Clinical Imaging Science Leads and be fully integrated within clinical study teams to ensure high-quality image acquisition, data integrity, and compliance with all study specific procedures. You should expect to work closely with our imaging vendor partners, the clinical operations function, the data management function, external clinical research organizations (CROs), and clinical sites to ensure the successful completion of startup activities, ongoing execution, and close-out of clinical studies.

What You'll Do:

• Imaging Startup and Project Management Support:Collaborate with clinical study leads and cross-functional teams to manage the start-up activities of imaging components in clinical trials. Assist with vendor selection, request for proposals, and timeline management.

• Study Documentation and Compliance:Author, review, and manage essential study documents such as Imaging Manuals, Independent Review Charters, Communication plans, data transmittal forms, Standard Operating Procedures, and Work Instructions. Ensure all documentation is audit-ready and filed appropriately in the Trial Master File (TMF).

• Site Management and Training:Provide technical support and training to clinical site personnel, which may include conducting site initiation visits or Teleconferences. Review and approve training materials for imaging facilities and/or clinical site personnel.

• Study maintenance: Track imaging progress during clinical studies and address imaging issues that may come up in close collaboration with clinical study teams, sites, and imaging CROs, including functional oversight through day to day monitoring of key performance indicators related to imaging timeliness, quality, etc., query resolution and troubleshooting

• Process Improvement:Participate in process improvement initiatives and ensure strict compliance with all procedures and regulations.

Let's find out if we're a fit:

• BA/BS with 5+ years of clinical trial imaging experience
• Certification as a Registered Technologist (R.T.) with experience in modalities like CT, MRI, or Nuclear Medicine is highly preferred
• Experience in imaging CRO oversight and implementation of quality control procedures
• Well-developed knowledge of the use of clinical imaging across multiple indications alongside knowledge of imaging vendor operational process.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)