Sr. Regulatory Manager

Optum NY/NJ, is seeking a Regulatory Manager to join our team in Westbury, NY. Optum is a clinician-led care organization that is changing the way clinicians work and live.  

As a member of the Optum Care Delivery team, you'll be an integral part of our vision to make healthcare better for everyone.

At Optum, you'll have the clinical resources, data and support of a global organization behind you so you can help your patients live healthier lives. We believe you deserve an exceptional career, and will empower you to live your best life at work and at home. Experience the fulfillment of advancing the health of your community with the excitement of contributing new practice ideas and initiatives that could help improve care for millions of patients across the country. Because together, we have the power to make health care better for everyone. Join us and discover how rewarding medicine can be while Caring. Connecting. Growing together.  

Primary Responsibilities: 

• Study start-up:
  • Prepare FDA 1572 with Principal Investigator, sub-Investigator, medical research facility, and clinical laboratory information
  • Distribute, collect, and track Financial Disclosure Forms for signatures from Principal Investigator and sub-Investigators
  • Submit Regulatory and Laboratory Documents via email and Investigator Portal
  • Back-up for distribution and collection of study Delegation of Authority Logs and Training Logs for signatures from Principal Investigator, sub-Investigators, Clinical Research Coordinators, and staff
  • Back-up for preparation, submission and obtaining initial approval from Institutional Review Boards
  • Participate in Site Initiation Visits
• Prepare and maintain site Study binders; distribute for signatures and collect updated FDA 1572, Financial Disclosure Forms, Delegation of Authority Logs, and Training Logs
• Collect and maintain current CVs, Medical Licenses, and Good Clinical Practice certificates for PI and sub-Investigators
• Prepare regulatory documents such as Protocol Signature Pages and Investigators' Brochures Acknowledgement of Receipts for Principal Investigator's signature
• Collect and maintain updated local laboratory documents from all affiliated sites
• Communicate with study monitors; supply updated study related documents as requested and answer questions regarding Regulatory documents
• Train on Interactive Web Response Systems for confirming shipment of Investigational Product
• Confirm shipment and inventory Investigational Product
• Prepare Investigational Product for distribution to clinical sites according to Sponsor protocol
• Back-up for study Continuing Review preparation, submission, and obtaining approval from Institutional Review Boards. Submission of changes in Research: change in PI, change in address, name, or the addition/removal of sites
• Back-up for Delegation and Training Logs updating with addition/removal of site staff. Staff notification of updated Protocol Amendments, Informed Consents, Training requirements and Informed Consent signature requirements
• Back-up for IP accountability, preparing Pharmacy Binder, and IP destruction for monitoring visits. Maintaining and recording daily temperatures
• Attend remote monitoring visits and study Close Out Visits
• Prepare, update, and distribute Patient Appointment Lists weekly to Optum Medical Care, PC Clinical Research Coordinators and staff
• Request CT and MRI scans on discs from local radiology departments and upload for Radiologists' review; collect and distribute reports to Principal Investigator, Research Coordinators, and staff
• Prepare, update, and distribute Protocol Flyers to Principal Investigator and sub-Investigators
• Prepare Subject and Informed Consent binders
• Inventory Central Laboratory Kits and Supplies; order as necessary
• Support Clinical Research Coordinators via phone calls, emails, and text messages in the following:
  • Assist in the preparation of subject eligibility packets for submission to the Clinical Trial Sponsors
  • Distribute Investigational Product to clinical sites for study subjects
  • Prepare and distribute central laboratory kits for monthly subject visits
  • Process and submit central laboratory specimens according to Sponsor protocol
  • Request Archival Tumor Tissue from local laboratories and submit to central laboratories according to Sponsor protocol
  • Collect and distribute central laboratory reports to Optum Medical Care, PC Clinical Research Coordinators
  • Answer queries from central laboratories

You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. 

Required Qualifications:  

• 3+ years of experience in clinical trial regulatory affairs experience within healthcare industry
• Experience preparing, reviewing, and submitting clinical trial applications, amendments, annual reports, and related regulatory documentation
• Experience working on cross-functional clinical development teams
• Demonstrated expertise in clinical trial regulatory activities - study start up, study maintenance and close out  
• Solid knowledge of ICH guidelines, GCP guidelines
• Proven ability to manage regulatory timelines and coordinate submissions across multiple studies and regions
• Excellent project management, organizational, and prioritization skills
• Outstanding written and verbal communication skills, including authoring regulatory documents and interacting with health authorities
• Ability to work independently while leading complex regulatory activities

Preferred Qualifications:    

• 5+ years of regulatory affairs experience
• Experience with decentralized clinical trials
• Knowledge of oncology clinical trials

Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The salary for this role will range from $91,700 - $163,700 annually based on full-time employment. We comply with all minimum wage laws as applicable.

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.    

UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.    

UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.